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Biosimilars Deals 2021

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast updates below.

Pearce IP BioBlast w/e 19 April 2024

On 21 April 2024, Swedish biosimilar developer Xbrane announced that the FDA issued a Complete Response Letter (CRL) regarding its BLA for ranibizumab biosimilar XlucaneTM.  The issues identified primarily concern (a) the analytical methods for the reference standard; and (b) pre-approval inspections of manufacturing partner’s sites.  The FDA has not requested additional clinical studies to demonstrate biosimilarity and has not requested reinspection of any site.

Xbrane will subsequently announce a resubmission date for the ranibizumab BLA.

On 19 April 2024, Merck (known as MSD outside Canada and the US) announced that Health Canada has approved Keytruda® (pembrolizumab) as a 1st line treatment for locally advanced unresectable or metastatic HER2 negative gastric cancer or gastroesophageal junction adenocarcinoma in combination with fluoropyrimidine and platinum-based chemotherapy.

Keytruda® was approved for the same indication in the US in November 2023 and in Korea in March 2024, while a positive CHMP recommendation was received in Europe in October 2023.

On 19 April 2024, Alvotech announced that it has entered a long-term agreement with an unnamed strategic partner to market in the US its high concentration interchangeable adalimumab-ryvk (AVT02), biosimilar to AbbVie’s Humira®, which received FDA approval in February 2023.  Teva will continue to commercialise adalimumab-ryvk under the SIMLANDI® brand in the US pursuant to its existing strategic partnership with Alvotech, which remains unchanged.

On 18 April 2024, Takeda announced FDA approval of subcutaneous administration of ENTYVIO® (vedolizumab) for maintaining therapy in adults with moderately to severely active Crohn’s disease (CD).

This follows the FDA’s acceptance of Takeda’s BLA for ENTYVIO® for the same indication, and the FDA’s approval of ENTYVIO® for ulcerative colitis (UC), in September 2023.

Vedolizumab biosimilars have previously been reported to be in development by Polpharma Biologics, Alvotech(under an agreement with Advanz) and Bio-Thera.

On 17 April 2024, Biocon announced that it signed an exclusive licensing and supply agreement for generic Ozempic® (semaglutide) in Brazil.  Biocon will develop, manufacture and supply the semaglutide product and Biomm is responsible for regulatory and commercialisation strategies in Brazil.

This follows news earlier this month that Hangzhou Jiuyan Gene Engineering’s application for a generic version of Ozempic® (semaglutide) was accepted by regulators in China.

On 16 April 2024, Alvotech announced the US has approved SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara®(ustekinumab), for both adult and paediatric use. Selarsdi™ was developed by Alvotech and will be commercialised by Teva in the US.

This is the second US biosimilar approved under the strategic agreement between Teva and Alvotech, following the FDA approval of Simlandi® (adalimumab) as an interchangeable biosimilar to AbbVie’s Humira® in February.

SELARSDI™ can be launched in the US from 21 February 2025, following Alvotech’s and Teva’s ustekinumab settlement with Johnson & Johnson in June 2023.

The Korea Biomedical Review reports that, on 16 April 2024, Merck Sharp & Dohme (MSD) announced that it obtained approval in Korea for an expanded indication for its Keytruda® (pembrolizumab) as a combination therapy with chemoradiotherapy for treating FIGO (International Federation of Genecology and Obstetrics) 2014 stage III-IVA cervical cancer.

The same indication was approved in the US by the FDA in January 2024.  This followed the FDA approval in October 2021 for Keytruda® plus chemotherapy, with or without bevacizumab, as a treatment for patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1.

On 15 April 2024, Fresenius Kabi announced its US launch of Tyenne® (tocilizumab-aazg), biosimilar to Roche’s Actemra® (tocilizumab) in both intravenous and subcutaneous formulations.  These formulations were FDA approved on 5 March 2024.   Tyenne is the third biosimilar product Fresenius Kabi has launched in the US.

Fresenius Kabi launched Tyenne® in Europe as the first to market biosimilar in November 2023 in both IV and subcutaneous formulations.

The Korea Times reports that Celltrion presented the 78-week results of its Phase 3 study of CT-P41, biosimilar to Amgen’s Prolia® (denosumab), at the World Congress on Osteoporosis held in London from 11-14 April 2024.  It is reported that the clinical trial showed CT-P41 has equivalent efficacy, pharmacokinetics and safety to Prolia® in postmenopausal women with osteoporosis.

Celltrion applied to the FDA for marketing authorisation of CT-P41 in December 2023.  The first Prolia® (denosumab) biosimilar approved in the US was Sandoz’s Jubbonti®, on 5 March 2024.

Prolia® (denosumab) biosimilars have been approved in Canada (Sandoz’s Jubbonti® on 20 February 2024) and China (Boan Biotech’s Boyoubei® in November 2022 and Mabwell’s Mailishu® in March 2023).  Other companies have Prolia® biosimilars under development including Samsung Bioepis, Alvotech, Intas, and Shanghai Henlius Biotech.

As previously reported, on 27 December 2023, and in a judgment published on 31 January 2024, the US District Court for the Northern District of West Virginia held that Mylan and Biocon infringed eight claims of Regeneron’s US patent 11,084,865, in respect of formulations of aflibercept such as Eylea®. The Judge found asserted claims of two aflibercept method of treatment patents (11,253,572 and 10,880,601) to be invalid.  Regeneron appealed and Mylan and Biocon filed cross-appeals.

On 12 April 2024, the Court of Appeals for the Federal Circuit dismissed the appeal and cross-appeals on the basis that all parties agreed that the Appeals Court lacked jurisdiction pending a decision of all patents in dispute.  This was agreed because only three patents out of the 24 asserted by Regeneron had been addressed in the 27 December 2023 decision and the infringement and validity of numerous patent claims are still pending in the proceeding.

A hearing of Regeneron’s motion for a permanent injunction following the Court’s decision that Mylan/Biocon infringe US 11,084,865 is scheduled for 2 May 2024, ahead of a status conference on 13 May 2024.

On 11 April 2024, the United States Judicial Panel on Multijurisdictional Litigation ruled that patent infringement actions brought by Regeneron regarding aflibercept biosimilars by Amgen, Mylan, Celltrion, Samsung Bioepis (2 actions) and Formycon involved “common questions of fact” and should be centralized in the Northern District of West Virginia.

Regeneron commenced five of its actions in the Northern District of West Virginia but commenced proceedings against Amgen in the Central District of California.  The Amgen case will now be transferred and assigned to Judge Kleeh who is hearing the remainder of the actions.

There are 63 patents in issue across each of the six actions.  In each case, Regeneron alleges infringement of a common set of 13 US patents covering its ophthalmic drug, Eylea® (aflibercept).

Of the common set of 13 patents, one (a formulation patent, US 11,084,865, expiring in June 2027) was held by Judge Kleeh to be valid and infringed in a decision issued in the first-filed Mylan action in December 2023.  Seven of the patents are at issue in preliminary injunction proceedings due to be heard on 2 May 2024 in the Northern District of West Virgina actions against Celltrion, Samsung Bioepis and Formycon.

Boston-based Ginkgo Bioworks announced on 10 April 2024 an expansion of its partnership with global healthcare leader, Novo Nordisk. This extended collaboration, set to span five years, is targeting improving the manufacturing of Novo Nordisk’s medicines with a focus on chronic diseases including diabetes and obesity.

Ginkgo Bioworks, known for its expertise in cell programming and biosecurity, will bring its synthetic biology platform to optimize Novo Nordisk’s R&D pipeline for serious chronic diseases.

This news follows the 25 March 2024 announcement by Novo Nordisk of its acquisition of Cardior Pharmaceuticals for (up to) € 1.025B.

On 10 April 2024, as a result of a settlement between the parties, the US District Court for the District of New Jersey dismissed all patent infringement claims in the proceeding brought by Genentech, Hoffmann-La Roche and Biogen against Dr Reddy’s Laboratories and Fresenius Kabi in respect of Dr Reddy’s proposed DRL_RI (rituximab), biosimilar to Genentech’s/Biogen’s Rituxan®.  The terms of the settlement between the parties have not been publicly disclosed.

The proceeding was commenced on 17 November 2023, following Dr Reddy’s submission of its aBLA to the FDA seeking approval for DRL_RI.  DRL_RI was to be commercialised by Fresenius in the US and by Dr Reddy’s in other jurisdictions.

Rituximab is an old molecule and was one of the first mAbs to become “biosimilar”, with the first rituximab approval in the US on 26 November 1997. There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020)Pfizer’s Rituxience® (launched in January 2020) and Amgen and Allergan’s RiabniTM (approved by the FDA in December 2020).

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Faran Shahzad

Faran Shahzad

Foreign Qualified Lawyer (NZ)

Faran is a Foreign Qualified intellectual property lawyer (NZ) with a particular focus on patents and trade marks, managing contentious and non-contentious patent and trade mark matters, and assists with office actions. 

With a background in physiology, Faran is passionate about life sciences industries.  His focus is on patent and trade mark legal issues relevant to pharmaceuticals, biopharmaceuticals, biotechnology, food technology, and animal health.   

The Carpark Patent Saga Continues – Infringement and Best Method

 

Date:

Court:

Adjudicator:

 

09 February 2024

Full Court of the Federal Court Australia

Burley, Jackson and Downes JJ

Highlight

The Full Federal Court has overturned the primary judge’s decision on construction and infringement (with respect to PinForce version 3) but upheld the primary judge’s decision on best method, in the latest case to be heard and decided in the long-running patent disputes between arch rivals in the field of carpark overstay detection.

Background

Vehicle Monitoring Systems (VMS) is the registered owner of two standard Australian patents, AU2005243110 and AU2011204924 (the standard patents), both entitled “Method, apparatus and system for parking overstay detection”.  The invention relates to monitoring the presence of a vehicle in a parking space over a specified time period via a detection apparatus located under the parking space in order to detect vehicles which overstay.  The main claim features relate to a method, apparatus and system incorporating the following steps or components for performing them:

  • detecting presence of a vehicle in said parking space;
  • processing and storing data relating to presence of said vehicle in the parking space;
  • determining whether the vehicle has overstayed in the parking space; and
  • wirelessly transmitting data relating to identified instances of vehicle overstay.

In February 2019 VMS commenced infringement proceedings against SARB Management Group Pty Ltd and its customer City of Melbourne in respect of three versions of SARB’s vehicle detection and sensor system known as ‘PinForce’.  SARB cross-claimed for invalidity.  In March 2023 Justice Besanko upheld the validity of the two VMS patents and found all three versions to be infringing.  SARB was also held liable for additional damages under s 122(1A) of the Patent Act 1990 (Cth) (Act) in respect of the first two iterations of the PinForce system in light of findings of infringement for a related innovation patent in earlier proceedings.  We reported Justice Besanko’s decision in a blog, in our Case Summary and this case was included in the Pearce IP 2023 Annual Patent Case Review.

SARB’s appeal to the Full Court of the Federal Court was confined to two issues:

  • construction and infringement of certain claims of AU2005243110, with respect to PinForce version 3; and
  • the primary judge’s finding that SARB had not established that the claims were invalid for lack of best method.

SARB succeeded on construction and infringement, but failed to prove lack of best method.

Key Issues

Construction and infringement

SARB’s challenge focussed on construction of independent claim 21 and omnibus claims 30-32.  Specifically, claim 21 covers:

  • ‘a system for identifying overstay of vehicles in parking spaces, said system comprising:
  • a plurality of battery-powered detection apparatuses for identifying overstay of vehicles in respective parking spaces when subterraneously installed; and
  • a data collection apparatus for wirelessly retrieving data from said plurality of battery-powered detection apparatuses, said data collection apparatus comprising:
  • …a processing unit coupled to said radio transmitter, said radio receiver and said memory unit;
  • said processing unit programmed to process said data received via said radio receiver and to indicate incidences of vehicle overstay to an operator;
  • said data relates to identified instances of vehicle overstay in a respective parking space’.

The primary judge construed the claim to include a system whereby the wireless ‘data collection apparatus’ (DCA) performed detection overstay utilising data sent by the subterranean ‘detection apparatus’ (DA) which comprised vehicle arrival time and duration but might fall short of overstay determination.

SARB contended that the primary judge should have found that claim 21 was limited to a system in which vehicle overstay is determined solely by the DA, and that such decision should then flow on to the omnibus claims.

In forming his view on construction of claim 21, the primary judge relied on:

  • the evidence of both parties’ experts, who agreed that the system disclosed in the patent was capable of determining overstay in the data collection apparatus; and
  • the body of the specification to aid his construction of claim 21, given that his Honour considered the phrase “said data relates to identified instances of vehicle overstay in a respective parking space” in claim 21 to be ambiguous. In particular, his Honour considered that there was an ambiguity in the phrase between data which includes the identified instances of vehicle overstay, that is, the determination of vehicle overstay, and data which may lead to the identification of instances of vehicle overstay.

His Honour concluded that the ambiguity in claim 21 should be resolved by holding that it includes a system in which vehicle overstay is determined by the DCA having regarding to a specific passage on page 7 (which stated “Alternatively, decisions relating to a vehicle overstay can be made by a data collection apparatus that collects data from the apparatus 200 via a radio communication link rather than by the apparatus 200”) , and, to a lesser extent, other passages relied on by VMS and its expert witness.

While the Full Court noted that the principles of claim construction are not in dispute, the Full Court disagreed with the primary judge that there was any ambiguity in claim 21.  In the Full Court’s view, the phrase “said data relates to identified instances of vehicle overstay in a respective parking space” (emphasis added) refers to data that relates to identified instances of vehicle overstay.  The Full Court went on to state at [60]:

As a matter of language, we understand this to mean first, that the detection apparatus will have already “identified” instances of vehicle overstay at the point that the data arrives at the processing unit. Secondly, the phrase “relates to” indicates that the “said data” not only consists of identified instances of overstay, but data that relates to it, such as details of current status, the amount of time the parking space has remained in the present state and records of vehicle movements. 

As a result, SARB also succeeded on claim 32 (the counterpart omnibus claim to claim 21).  In addition, SARB succeeded on claims 30 and 31, as VMS accepted that these claims did not disclose a method or apparatus in which the DCA determined vehicle overstay.

Best method

SARB also appealed the primary judge’s finding that SARB failed to establish the patents were invalid on the ground of best method.  The basis of SARB’s argument on best method was that the patent did not describe a specific transceiver (the ASTRX2 transceiver), even though it was known to the inventor to have advantages which made it the best transceiver for communicating data from the subterraneous detection apparatus.  These advantages related to its ‘wake-up’ method, ie the manner in which it woke up to receive the data.  SARB’s argument was not specifically to failure to disclose the transceiver per se, but failure to fully disclose the wake-up scheme of the invention because the patent did not describe the ASTRX2 transceiver.  The Full Court rejected SARB’s argument, agreeing with the primary judge that the invention of the patents related to the wake-up scheme and not the wake-up scheme as carried out by a transceiver with particular features.  In coming to this conclusion, the Court emphasised the significance of the embodiments in the specification in identifying the invention, whereas SARB had focussed on the consistory clauses to the challenged claims.  The Court held the disclosure was adequate because the parameters of the wake-up scheme were clearly disclosed in the specification, and there was no evidence that transceivers other than the ASTRX2 could not meet those parameters.

Outcome

The Full Court overturned the primary judge’s decision finding that the claims should be construed to encompass a system where vehicle detection is determined by the DCA.  The effect of this change in construction was that the PinForce version 3 was held to fall outside the claims.  It was agreed by all experts before Justice Besanko that in the case of PinForce Version 3, all capability of determining overstay in the DA had been removed following a redesign.

However, the Full Court agreed with the primary judge on best method, holding that SARB had not proved a failure to disclose the best method.

Implications

The Full Court’s decision clearly illustrates the principles applied to claim construction including that the scope of an otherwise clear claim cannot be broadened or changed based on language drawn from the body of the specification.  The Full Court’s decision also confirms the narrow construction which Courts give to omnibus claims.  It also provides further guidance on the ground of lack of best method, a revocation ground peculiar to Australia and one which has been increasingly run in Australia over the last decade.  In particular, the Full Court’s judgment highlights the importance of identifying the invention the subject of the patent to the determination of whether the patent has met the best method disclosure requirement.

 

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Helen Macpherson

Helen Macpherson

Executive, Lawyer

Helen has over 25 years’ experience as an intellectual property specialist and is recognised as an industry leader. Helen advises on all forms of intellectual property including patents, plant breeder’s rights, trade marks, copyright and confidential information across a wide range of industries, including the pharmaceutical/biopharmaceutical, biotechnology, medical device, life sciences, agricultural, manufacturing and tech sectors.

Xbrane to Resubmit BLA for Ranibizumab Biosimilar following FDA CRL

On 21 April 2024, Swedish biosimilar developer Xbrane announced that the FDA issued a Complete Response Letter (CRL) regarding its BLA for ranibizumab biosimilar XlucaneTM.  The issues identified primarily concern (a) the analytical methods for the reference standard; and (b) pre-approval inspections of manufacturing partner’s sites.  The FDA has not requested additional clinical studies to demonstrate biosimilarity and has not requested reinspection of any site.

Xbrane will subsequently announce a resubmission date for the ranibizumab BLA.

New Indication Alert: MSD’s Keytruda® (pembrolizumab) Approved in Canada for New Gastric Cancer Indication

On 19 April 2024, Merck (known as MSD outside Canada and the US) announced that Health Canada has approved Keytruda® (pembrolizumab) as a 1st line treatment for locally advanced unresectable or metastatic HER2 negative gastric cancer or gastroesophageal junction adenocarcinoma in combination with fluoropyrimidine and platinum-based chemotherapy.

Keytruda® was approved for the same indication in the US in November 2023 and in Korea in March 2024, while a positive CHMP recommendation was received in Europe in October 2023.

Alvotech Enters Further US Partnership Agreement for Adalimumab Biosimilar

On 19 April 2024, Alvotech announced that it has entered a long-term agreement with an unnamed strategic partner to market in the US its high concentration interchangeable adalimumab-ryvk (AVT02), biosimilar to AbbVie’s Humira®, which received FDA approval in February 2023.  Teva will continue to commercialise adalimumab-ryvk under the SIMLANDI® brand in the US pursuant to its existing strategic partnership with Alvotech, which remains unchanged.

NEW INDICATION ALERT – FDA Approves Takeda’s ENTYVIO® (vedolizumab) for Crohn’s Maintenance

On 18 April 2024, Takeda announced FDA approval of subcutaneous administration of ENTYVIO® (vedolizumab) for maintaining therapy in adults with moderately to severely active Crohn’s disease (CD).

This follows the FDA’s acceptance of Takeda’s BLA for ENTYVIO® for the same indication, and the FDA’s approval of ENTYVIO® for ulcerative colitis (UC), in September 2023.

Vedolizumab biosimilars have previously been reported to be in development by Polpharma Biologics, Alvotech(under an agreement with Advanz) and Bio-Thera.

Celltrion wins Denmark’s national bid for Remsima SC®

On April 2024, Korean Biomedical Review reported that Celltrion won the Denmark national tender for its subcutaneous infliximab formulation, Remsima SC®.  Remsima SC® (infliximab) will be supplied in Denmark for one year by Celltrion’s Danish subsidiary. This subsidiary is planning to expand its marketing team and initiate marketing activities to increase the prescription rate of the product.

This comes after Celltrion’s successful bids for the supply of Remsima SC® (infliximab) in the Netherlands and Norway earlier this year.

Biocon and Biomm Enter Agreement To Supply Generic Ozempic® (semaglutide) in Brazil

On 17 April 2024, Biocon announced that it signed an exclusive licensing and supply agreement for generic Ozempic® (semaglutide) in Brazil.  Biocon will develop, manufacture and supply the semaglutide product and Biomm is responsible for regulatory and commercialisation strategies in Brazil.

This follows news earlier this month that Hangzhou Jiuyan Gene Engineering’s application for a generic version of Ozempic® (semaglutide) was accepted by regulators in China.

Approval Alert: FDA Approves Alvotech & Teva’s Ustekinumab, Selarsdi™

On 16 April 2024, Alvotech announced the US has approved SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara®(ustekinumab), for both adult and paediatric use. Selarsdi™ was developed by Alvotech and will be commercialised by Teva in the US.

This is the second US biosimilar approved under the strategic agreement between Teva and Alvotech, following the FDA approval of Simlandi® (adalimumab) as an interchangeable biosimilar to AbbVie’s Humira® in February.

SELARSDI™ can be launched in the US from 21 February 2025, following Alvotech’s and Teva’s ustekinumab settlement with Johnson & Johnson in June 2023.

New Indication Alert: MSD’s Keytruda® Obtains Approval for Cervical Cancer Indication in Korea

The Korea Biomedical Review reports that, on 16 April 2024, Merck Sharp & Dohme (MSD) announced that it obtained approval in Korea for an expanded indication for its Keytruda® (pembrolizumab) as a combination therapy with chemoradiotherapy for treating FIGO (International Federation of Genecology and Obstetrics) 2014 stage III-IVA cervical cancer.

The same indication was approved in the US by the FDA in January 2024.  This followed the FDA approval in October 2021 for Keytruda® plus chemotherapy, with or without bevacizumab, as a treatment for patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1.

Fresenius Launches Biosimilar Tocilizumab in the US

On 15 April 2024, Fresenius Kabi announced its US launch of Tyenne® (tocilizumab-aazg), biosimilar to Roche’s Actemra® (tocilizumab) in both intravenous and subcutaneous formulations.  These formulations were FDA approved on 5 March 2024.   Tyenne is the third biosimilar product Fresenius Kabi has launched in the US.

Fresenius Kabi launched Tyenne® in Europe as the first to market biosimilar in November 2023 in both IV and subcutaneous formulations.

Celltrion Presents Phase 3 Results for Denosumab Biosimilar

The Korea Times reports that Celltrion presented the 78-week results of its Phase 3 study of CT-P41, biosimilar to Amgen’s Prolia® (denosumab), at the World Congress on Osteoporosis held in London from 11-14 April 2024.  It is reported that the clinical trial showed CT-P41 has equivalent efficacy, pharmacokinetics and safety to Prolia® in postmenopausal women with osteoporosis.

Celltrion applied to the FDA for marketing authorisation of CT-P41 in December 2023.  The first Prolia® (denosumab) biosimilar approved in the US was Sandoz’s Jubbonti®, on 5 March 2024.

Prolia® (denosumab) biosimilars have been approved in Canada (Sandoz’s Jubbonti® on 20 February 2024) and China (Boan Biotech’s Boyoubei® in November 2022 and Mabwell’s Mailishu® in March 2023).  Other companies have Prolia® biosimilars under development including Samsung Bioepis, Alvotech, Intas, and Shanghai Henlius Biotech.

Pearce IP BioBlast w/e 12 April 2024

On 11 April 2024, the United States Judicial Panel on Multijurisdictional Litigation ruled that patent infringement actions brought by Regeneron regarding aflibercept biosimilars by Amgen, Mylan, Celltrion, Samsung Bioepis (2 actions) and Formycon involved “common questions of fact” and should be centralized in the Northern District of West Virginia.

Regeneron commenced five of its actions in the Northern District of West Virginia but commenced proceedings against Amgen in the Central District of California.  The Amgen case will now be transferred and assigned to Judge Kleeh who is hearing the remainder of the actions.

There are 63 patents in issue across each of the six actions.  In each case, Regeneron alleges infringement of a common set of 13 US patents covering its ophthalmic drug, Eylea® (aflibercept).

Of the common set of 13 patents, one (a formulation patent, US 11,084,865, expiring in June 2027) was held by Judge Kleeh to be valid and infringed in a decision issued in the first-filed Mylan action in December 2023.  Seven of the patents are at issue in preliminary injunction proceedings due to be heard on 2 May 2024 in the Northern District of West Virgina actions against Celltrion, Samsung Bioepis and Formycon.

On 12 April 2024, Korea Biomedical Review reported that Samsung Bioepis received Korean approval for EpyztekTM(SB17), biosimilar to Janssen’s Stelara® (ustekinumab), for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.  EpyztekTM is the first ustekinumab biosimilar approved in Korea.

Samsung Bioepis presented Phase 3 results for SB17 at the American Academy of Dermatology Annual Meeting last month, demonstrating equivalence to Stelara® in efficacy and safety.

Under the brand name PyzchivaTM, SB17 was recommended for approval by the EU’s Committee for Medicinal Products for Human Use in February 2024.  Samsung Bioepis also has a BLA for SB17 under review by the FDA, although Samsung cannot commercialise SB17 in the US until 22 February 2025 under a settlement and licence agreement with J&J.  If approved in the US and EU, SB17 will be commercialised by Sandoz pursuant to a deal entered into with Samsung Bioepis in September 2023.

Samsung Bioepis has applied to revoke at least two of Janssen’s Stelara® (ustekinumab) Australian patents in the Australian Federal Court. The trial is provisionally scheduled for November 2024.

On 11 April 2024, Formycon AG and Bioeq AG announced the launch of Lucentis® (ranibizumab)  biosimilar FYB201 in Canada and Switzerland.  Health Canada granted marketing authorization under the tradename RanoptoTM, and Swissmedic has approved FYB201 under the tradename Ranivisio®.

FYB201 was developed by Bioeq AG subject to the joint venture between Formycon AG and Polpharma Biologics Group BV.  In mid 2021, Bioeq entered an exclusive commercialisation agreement with Teva for FYB201 in Canada and Europe (among other regions).

On 11 April 2024, Business Korea published that Celltrion has been granted a formulation patent (US 11 951 207) for its ZYMFENTRA®. ZYMFENTRA® is the world’s first self-developed subcutaneous injection of infliximab for treating autoimmune diseases.  Celltrion claims to have exclusive rights to its subcutaneous formulation until the patent’s “expiration in 2038”.

On 17 March 2024, Celltrion USA launched ZYMFENTRA™ (infliximab-dyyb), the first US Approved subcutaneous formulation of infliximab (approved by the U.S. FDA in 2023).

On 8 April 2024, Samsung Bioepis released its fifth US Biosimilar Market Report.  The quarterly report details average sales price information for US launched biosimilars and market share and price trends.

The Q2 2024 Report notes that as of April 2024, the FDA has approved 48 biosimilars, with three of those (Alvotech’s/Teva’s Simlandi® (Humira®, adalimumab), Sandoz’s Jubbonti®/Wyost® (Prolia®/Xgeva®, denosumab) and Fresenius Kabi’s Tyenne® (Actemra®, tocilizumab) approved in the last quarter.  38 of the 48 approved biosimilars have launched in the US.

Samsung Bioepis reports that, on average, biosimilars in the US have gained 53% market share within 3 years post initial launch.  As at Q4 2023, the adalimumab biosimilars share of the US adalimumab market was 4%, although this was up 2% compared with last quarter. The first biosimilar was launched in January 2023 (Amjevita™, Amgen) and multiple additional biosimilars entered the US market in July 2023.

On 8 April 2024, PR Newswire reported Mabwell’s MAIWEIJIANTM (denosumab 120mg) (biosimilar to Amgen’s Prolia®) received marketing approval in China.  MAIWEIJIAN was developed by Mabwell’s wholly owned subsidiary T-mab.  It is approved in China for the treatment of giant cell tumour of the bone that is unresectable or where surgical resection may lead to severe functional impairment.

Results of Mabwell’s Phase III trials were published in JAMA Oncology in February 2024 .  In March 2023, Mabwell announced that it received Chinese marketing approval for Mailishu® (denosumab), biosimilar to Amgen’s Prolia®.

The Australian Therapeutic Goods Administration (TGA) has updated its register of prescription medicines under evaluation adding 11 new medicines which were accepted for review between February and March 2024.  Amongst others, the register shows:

In February:

  • MSD’s Keytruda® (pembrolizumab) was accepted for review for a new indication treating patients with locally advanced or metastatic urothelial carcinoma;
  • Amgen’s blinatumomab was accepted for review for the treatment of B-cell precursor acute lymphoblastic leukemia in the consolidation phase; and
  • Novo Nordisk’s Refixia® (nonacog beta pegol) was accepted for review for the treatment and prophylaxis of bleeding in patients with haemophilia B.

In March:

  • BMS’ nivolumab and Pfizer’s marstacimab were accepted for evaluation; and
  • MSD’s sotatercept (Australian brand name yet to be confirmed) was accepted for evaluation for the treatment of pulmonary arterial hypertension.

The TGA acceptance of MSD’s sotatercept comes after MSD’s WinrevairTM (sotatercept) was approved in the US by the FDA in March 2024.

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Faran Shahzad

Faran Shahzad

Foreign Qualified Lawyer (NZ)

Faran is a Foreign Qualified intellectual property lawyer (NZ) with a particular focus on patents and trade marks, managing contentious and non-contentious patent and trade mark matters, and assists with office actions. 

With a background in physiology, Faran is passionate about life sciences industries.  His focus is on patent and trade mark legal issues relevant to pharmaceuticals, biopharmaceuticals, biotechnology, food technology, and animal health.   

Aflibercept Appeals Dismissed for Lack of Jurisdiction

As previously reported, on 27 December 2023, and in a judgment published on 31 January 2024, the US District Court for the Northern District of West Virginia held that Mylan and Biocon infringed eight claims of Regeneron’s US patent 11,084,865, in respect of formulations of aflibercept such as Eylea®. The Judge found asserted claims of two aflibercept method of treatment patents (11,253,572 and 10,880,601) to be invalid.  Regeneron appealed and Mylan and Biocon filed cross-appeals.

On 12 April 2024, the Court of Appeals for the Federal Circuit dismissed the appeal and cross-appeals on the basis that all parties agreed that the Appeals Court lacked jurisdiction pending a decision of all patents in dispute.  This was agreed because only three patents out of the 24 asserted by Regeneron had been addressed in the 27 December 2023 decision and the infringement and validity of numerous patent claims are still pending in the proceeding.

A hearing of Regeneron’s motion for a permanent injunction following the Court’s decision that Mylan/Biocon infringe US 11,084,865 is scheduled for 2 May 2024, ahead of a status conference on 13 May 2024.

Six Regeneron Aflibercept US Patent Infringement Actions to be Centralized in West Virginia

On 11 April 2024, the United States Judicial Panel on Multijurisdictional Litigation ruled that patent infringement actions brought by Regeneron regarding aflibercept biosimilars by Amgen, Mylan, Celltrion, Samsung Bioepis (2 actions) and Formycon involved “common questions of fact” and should be centralized in the Northern District of West Virginia.

Regeneron commenced five of its actions in the Northern District of West Virginia but commenced proceedings against Amgen in the Central District of California.  The Amgen case will now be transferred and assigned to Judge Kleeh who is hearing the remainder of the actions.

There are 63 patents in issue across each of the six actions.  In each case, Regeneron alleges infringement of a common set of 13 US patents covering its ophthalmic drug, Eylea® (aflibercept).

Of the common set of 13 patents, one (a formulation patent, US 11,084,865, expiring in June 2027) was held by Judge Kleeh to be valid and infringed in a decision issued in the first-filed Mylan action in December 2023.  Seven of the patents are at issue in preliminary injunction proceedings due to be heard on 2 May 2024 in the Northern District of West Virgina actions against Celltrion, Samsung Bioepis and Formycon.

Approval Alert: Samsung Bioepis First Korean Approved Ustekinumab Biosimilar

On 12 April 2024, Korea Biomedical Review reported that Samsung Bioepis received Korean approval for EpyztekTM(SB17), biosimilar to Janssen’s Stelara® (ustekinumab), for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.  EpyztekTM is the first ustekinumab biosimilar approved in Korea.

Samsung Bioepis presented Phase 3 results for SB17 at the American Academy of Dermatology Annual Meeting last month, demonstrating equivalence to Stelara® in efficacy and safety.

Under the brand name PyzchivaTM, SB17 was recommended for approval by the EU’s Committee for Medicinal Products for Human Use in February 2024.  Samsung Bioepis also has a BLA for SB17 under review by the FDA, although Samsung cannot commercialise SB17 in the US until 22 February 2025 under a settlement and licence agreement with J&J.  If approved in the US and EU, SB17 will be commercialised by Sandoz pursuant to a deal entered into with Samsung Bioepis in September 2023.

Samsung Bioepis has applied to revoke at least two of Janssen’s Stelara® (ustekinumab) Australian patents in the Australian Federal Court. The trial is provisionally scheduled for November 2024.

Formycon AG & Bioeq AG Launch Lucentis® (ranibizumab) Biosimilar in Canada and Switzerland

On 11 April 2024, Formycon AG and Bioeq AG announced the launch of Lucentis® (ranibizumab)  biosimilar FYB201 in Canada and Switzerland.  Health Canada granted marketing authorization under the tradename RanoptoTM, and Swissmedic has approved FYB201 under the tradename Ranivisio®.

FYB201 was developed by Bioeq AG subject to the joint venture between Formycon AG and Polpharma Biologics Group BV.  In mid 2021, Bioeq entered an exclusive commercialisation agreement with Teva for FYB201 in Canada and Europe (among other regions).

Celltrion Obtains US Formulation Patent for Subcutaneous Infliximab (Zymfentra®)

On 11 April 2024, Business Korea published that Celltrion has been granted a formulation patent (US 11 951 207) for its ZYMFENTRA®. ZYMFENTRA® is the world’s first self-developed subcutaneous injection of infliximab for treating autoimmune diseases.  Celltrion claims to have exclusive rights to its subcutaneous formulation until the patent’s “expiration in 2038”.

On 17 March 2024, Celltrion USA launched ZYMFENTRA™ (infliximab-dyyb), the first US Approved subcutaneous formulation of infliximab (approved by the U.S. FDA in 2023).

Ginkgo Bioworks to Improve Novo Nordisk’s Chronic Disease Medications Manufacturing Over 5 Years

Boston-based Ginkgo Bioworks announced on 10 April 2024 an expansion of its partnership with global healthcare leader, Novo Nordisk. This extended collaboration, set to span five years, is targeting improving the manufacturing of Novo Nordisk’s medicines with a focus on chronic diseases including diabetes and obesity.

Ginkgo Bioworks, known for its expertise in cell programming and biosecurity, will bring its synthetic biology platform to optimize Novo Nordisk’s R&D pipeline for serious chronic diseases.

This news follows the 25 March 2024 announcement by Novo Nordisk of its acquisition of Cardior Pharmaceuticals for (up to) € 1.025B.

Genentech & Dr Reddy’s Settle US Rituximab Dispute

On 10 April 2024, as a result of a settlement between the parties, the US District Court for the District of New Jersey dismissed all patent infringement claims in the proceeding brought by Genentech, Hoffmann-La Roche and Biogen against Dr Reddy’s Laboratories and Fresenius Kabi in respect of Dr Reddy’s proposed DRL_RI (rituximab), biosimilar to Genentech’s/Biogen’s Rituxan®.  The terms of the settlement between the parties have not been publicly disclosed.

The proceeding was commenced on 17 November 2023, following Dr Reddy’s submission of its aBLA to the FDA seeking approval for DRL_RI.  DRL_RI was to be commercialised by Fresenius in the US and by Dr Reddy’s in other jurisdictions.

Rituximab is an old molecule and was one of the first mAbs to become “biosimilar”, with the first rituximab approval in the US on 26 November 1997. There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020)Pfizer’s Rituxience® (launched in January 2020) and Amgen and Allergan’s RiabniTM (approved by the FDA in December 2020).

H.A.S. Real Estate Wins The (Branding) War But Loses The (Indemnity Costs) Battle

 

Date:

Court:

Adjudicator:

 

02 April 2024

Full Court of the Federal Court Australia

Yates, Markovic and Kennett JJ

In a decision handed down on 2 April 2024 by the Full Federal Court, H.A.S Real Estate (H.A.S) has failed in its application for indemnity costs. The Court’s unanimous judgment by Justices Yates, Markovic and Kennett emphasises the critical importance of ensuring that an offer of compromise aligns with the orders and remedies which a party can receive through the court process. In this case, H.A.S’ offer included “an extraneous payment unconnected to the fate of the litigation”.

The case involved a Federal Court branding dispute between two real estate groups operating in Sydney.  The Agency Group and its subsidiaries (the Agency) brought proceedings against H.A.S alleging that H.A.S had infringed the Agency’s registered trade mark rights and engaged in misleading and deceptive conduct in contravention of s 18 of the Australian Consumer Law.  Justice Jackman (the primary judge) dismissed the Agency’s lawsuit in May 2023.  The Agency appealed to the Full Federal Court and, was dealt a second setback when the Court dismissed the appeal and ordered that the Agency pay H.A.S’ appeal costs.

H.A.S sought an order that its costs of the appeal should be paid on an indemnity basis because the Agency unreasonably failed to accept its offer of compromise. The H.A.S offer that was made during the appeal (the Second H.A.S Offer) largely mirrored an offer made in the primary proceeding (the First H.A.S Offer). Regarding the First H.A.S Offer, the primary judge found it was “unreasonable” for the Agency to reject the offer and ordered it to pay H.A.S’ costs of the primary proceeding on an indemnity basis from the date the offer was rejected.

The Second H.A.S Offer included an additional $10,000 to be paid to H.A.S for the cost of re-branding. The Agency asserted that rejecting the Second H.A.S Offer was not unreasonable, for two reasons:

  • it was not unreasonable for the Agency to appeal the primary judge’s decision, given the evaluative nature of legal questions arising where there are issues of deceptive similarity for brands; and
  • at the time the offer was made, the only justifiable financial contribution the Agency could have paid to H.A.S as a compromise, was a reasonable proportion of H.A.S’ appeal costs at that time. The total financial contribution sought by H.A.S ($30,000) exceeded its actual appeal costs at the date of the Second H.A.S Offer.

The Court rejected the order for costs to be paid on an indemnity basis.  The Court agreed with the Agency that it was not unreasonable for it to reject the Second H.A.S Offer, because:

  • at the time the offer of compromise was made, it could not be said that the appeal had no prospects of success or was “plainly unmeritorious”; and
  • H.A.S would not have been able to recover the re-branding costs from the Agency by way of court order.

The Court also noted that the offer of compromise did not purport to affect the costs orders made by the primary judge. Had the appeal been successful, it is likely that the primary judge’s costs orders would have been set aside. However, acceptance of the offer meant that the adverse costs order made below would have remained in place, even though the award of those costs was in dispute in the appeal.

This case illustrates:

  • the precision required in crafting offers of compromise to leave open the option of indemnity costs.
  • the importance of ensuring that any compromise offer aligns with the orders and remedies which a party can receive through the court process.

In this case, a key factor militating against an indemnity costs order was that the offer included a requirement for the Agency to contribute to the payment of H.A.S’s rebranding costs when H.A.S. “… was never able to recover its costs of re-branding (and, therefore, any contribution to those costs) from the Agency by way of court order in the appeal or in the primary proceeding”.

 

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Helen Macpherson

Helen Macpherson

Executive, Lawyer

Helen has over 25 years’ experience as an intellectual property specialist and is recognised as an industry leader. Helen advises on all forms of intellectual property including patents, plant breeder’s rights, trade marks, copyright and confidential information across a wide range of industries, including the pharmaceutical/biopharmaceutical, biotechnology, medical device, life sciences, agricultural, manufacturing and tech sectors.

Samsung Bioepis Releases Fifth Biosimilar Market Report: Adalimumab Biosimilar Uptake at 4% Following First Year of Biosimilar Competition

On 8 April 2024, Samsung Bioepis released its fifth US Biosimilar Market Report.  The quarterly report details average sales price information for US launched biosimilars and market share and price trends.

The Q2 2024 Report notes that as of April 2024, the FDA has approved 48 biosimilars, with three of those (Alvotech’s/Teva’s Simlandi® (Humira®, adalimumab), Sandoz’s Jubbonti®/Wyost® (Prolia®/Xgeva®, denosumab) and Fresenius Kabi’s Tyenne® (Actemra®, tocilizumab) approved in the last quarter.  38 of the 48 approved biosimilars have launched in the US.

Samsung Bioepis reports that, on average, biosimilars in the US have gained 53% market share within 3 years post initial launch.  As at Q4 2023, the adalimumab biosimilars share of the US adalimumab market was 4%, although this was up 2% compared with last quarter. The first biosimilar was launched in January 2023 (Amjevita™, Amgen) and multiple additional biosimilars entered the US market in July 2023.

Approval Alert: Mabwell’s MAIWEIJIAN™ is First Chinese Approved Denosumab Biosimilar

On 8 April 2024, PR Newswire reported Mabwell’s MAIWEIJIANTM (denosumab 120mg) (biosimilar to Amgen’s Prolia®) received marketing approval in China.  MAIWEIJIAN was developed by Mabwell’s wholly owned subsidiary T-mab.  It is approved in China for the treatment of giant cell tumour of the bone that is unresectable or where surgical resection may lead to severe functional impairment.

Results of Mabwell’s Phase III trials were published in JAMA Oncology in February 2024 .  In March 2023, Mabwell announced that it received Chinese marketing approval for Mailishu® (denosumab), biosimilar to Amgen’s Prolia®.

Pearce IP BioBlast w/e 05 April 2024

On 5 April 2024, Samsung Bioepis announced the commencement of Phase 3 clinical trials for SB27, biosimilar to MSD’s Keytruda® (pembrolizumab) in patients with metastatic non-squamous non-small cell lung cancer (NCT06348199).

Biocad initiated phase 1 clinical trials for its pembrolizumab biosimilar  BCD-201 in July 2022.  Sandoz anticipates commencing phase 1 clinical trials for its pembrolizumab biosimilar  in 2024.  Formycon, Xbrane, and Celltrion have each previously announced their development of pembrolizumab biosimilars.

On 5 April 2024, Shanghai Henlius Biotech (SHB) announced that its phase 3 studies confirmed that HLX14 (denosumab) is equivalent in efficacy, safety, tolerability and immunogenicity to Amgen’s Prolia®.  HLX14 will be indicated for the treatment of osteoporosis in postmenopausal women at high risk of fracture.

SHB announced the successful completion of its phase 1 clinical trials of HLX14 in January 2024.

In June 2022, SHB announced its licence agreement with Organon under which Organon received exclusive global commercialisation rights to HLX14, excluding China, Hong Kong, Macau and Taiwan.

On 4 April 2024, each of Teva Pharmaceuticals and Fresenius Kabi-owned mAbxience announced a strategic licensing agreement relating to an unnamed biosimilar which is already in development for the treatment of multiple oncology conditions.  The deal covers multiple markets, including the Europe and the United States.  MAbxience offers its biosimilar development expertise and manufacturing facilities in Spain and Argentina whilst Teva will oversee the regulatory processes and commercialisation.

The Korea Biomedical Review reported that, on 3 April 2024, the Korean Ministry of Food and Drug Safety approved Regeneron’s and Bayer’s Eylea® (aflibercept) 8mg intravitreal injection for the treatment of nAMD and DME.

High Dose Eylea® has previously been approved in multiple countries including the US (August 2023 – nAMD, DME and diabetic retinopathy), the EU (January 2024 – nAMD and DME) and Japan (January 2024 – nAMD and DME).

On 3 April 2024, Australia’s PBAC published the July 2024 Meeting Agenda.  On the list of drugs seeking to be PBS reimbursed is Sandoz’s high concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab).  Hyrimoz® is currently PBS-listed in a 40mg/0.8mL form and reimbursement is now being sought for 20mg/0.2mL, 40mg/0.4ml and 80mg/0.8ml forms.

Sandoz launched its high concentration formulation of Hyrimoz® in Europe in November 2023 and in the US in July 2023.

Also on the PBAC July Agenda are applications for new PBS-listings of:

  • Eisai’s Leqembi® (lecanemab) for the treatment of early Alzheimer’s disease and Pfizer’s multiple myeloma treatment Elrexfio® (elranatamab), which are each yet to be TGA-approved; and
  • Sanofi’s Beyfortux® (nirsevimab) for the prevention of respiratory syncytial virus in babies, approved by the TGA in November 2023.

Roche has applied to PBS-list a new indication (retinal vein occlusion) and new PFS form of its Vabysmo® (faricimab).

BMS is seeking to vary the existing listings for nivolumab and ipilimumab, and Takeda is seeking authority script listing for vedolizumab for continuing treatment of chronic pouchitis.

The reimbursement of Novo Nordisk’s PBS listed Ozempic® (semaglutide) (and other GLP-1 analogues) for the treatment of type 2 diabetes mellitus will also be considered.

On 2 April 2024, Hangzhou Jiuyan Gene Engineering announced the acceptance of its Chinese application for JiyoutaiTM, biosimilar to Novo Nordisk’s Ozempic® (semaglutide), for type 2 diabetes.  This application is reportedly the first in PRC for a semaglutide biosimilar.

According to Novo’s 2023 annual report, patent protection in China for Ozempic expires in 2026.

On 2 April 2024, Korea Biomedical Review reported Samsung Bioepis’ Korean launch of Epysqli®, biosimilar to AstraZeneca’s Soliris® (eculizumab), with a 30% price reduction.  Soliris®, developed by Alexion Pharmaceuticals and marketed by AstraZeneca, is used for the treatment of rare conditions such as paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.  The annual cost for treatment with Soliris® is approximately 400 million won per patient.

Samsung Bioepis launched Epysqli® in three European countries on 19 October 2023.  Epysqli® was approved by the EMA on 30 May 2023.

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Faran Shahzad

Faran Shahzad

Foreign Qualified Lawyer (NZ)

Faran is a Foreign Qualified intellectual property lawyer (NZ) with a particular focus on patents and trade marks, managing contentious and non-contentious patent and trade mark matters, and assists with office actions. 

With a background in physiology, Faran is passionate about life sciences industries.  His focus is on patent and trade mark legal issues relevant to pharmaceuticals, biopharmaceuticals, biotechnology, food technology, and animal health.