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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.

BioBlast w/e 24 Mar 23: IPRs re Regeneron aflibercept patents | NMPA approves Xgeva® (denosumab) | FDA approves Hyrimoz® (adalimumab) | and more…

Significant biosimilar activities this week include:

22 March 2023 | US | PTAB institutes Celltrion and Samsung IPRs re Regeneron’s key aflibercept patents

21 March 2023 | CN | China’s NMPA accepts BLA for Boan Biotech’s biosimilar to Amgen’s Xgeva® (denosumab)

21 March 2023 | US | AbbVie Humira empire spirals as FDA approves Sandoz adalimumab biosimilar Hyrimoz®

21 March 2023 | EU | New Indication Alert: EC approves Regeneron / Sanofi’s Dupixent® (dupilumab) for children 6 months+

15 March 2023 | CN | Janssen’s redacted public brief in support of preliminary injunction regarding Amgen’s Stelara® (ustekinemab) biosimilar

PTAB institutes Celltrion and Samsung IPRs re Regeneron’s key aflibercept patents

PTAB instituted Celltrion’s IPR challenges to US 10,888,601 (decision here) and US 10,130,681 (decision here) and Samsung Bioepis’ IPR challenge to US 10,888,601 (decision here).  PTAB also granted Celltrion and Samsung Bioepis’ motions to join these IPRs with the earlier IPRs filed against the same Regeneron patents by Mylan in July 2022 which were instituted in January 2023.  Celltrion and Samsung Bioepis sought to join the Mylan IPRs in February 2023.

Note:

New Indication Alert: EC approves Regeneron / Sanofi’s Dupixent® (dupilumab) for children 6 months+

Regeneron and Sanofi announced European Commission approval of Dupixent® (dupilumab) for the treatment of children aged six months to five years old with severe atopic dermatitis.  Dupilumab is the only targeted medicine to treat this condition in young children approved in Europe and the US.  The approval was based on data from a phase III clinical trial published in the Lancet.

This comes after Regeneron and Sanofi recently announced that the FDA accepted their sBLA for Dupixent® (dupilumab) to treat chronic spontaneous urticaria.

AbbVie Humira® empire spirals as FDA approves Sandoz adalimumab biosimilar Hyrimoz®

Sandoz announced that it has received FDA approval for its Hyrimoz® (adalimumab), biosimilar to AbbVie’s Humira® in a citrate-free, high concentration formulation that it intends to launch in the US on 1 July 2023 pursuant to the licence granted in its settlement with AbbVie on 11 October 2018.  Hyrimoz® is approved for the same seven indications as the reference product, AbbVie’s Humira®.

This follows Amgen’s recent launch of Amjevita®, the first adalimumab biosimilar available in the US on 31 January 2023 pursuant to its AbbVie settlement dated 28 September 2017.  In total, AbbVie entered into 11 deals with biosimilar entrants enabling US market entry as follows: Amgen (31 January 2023), Alvotech (1 July 2023), Celltrion (July 2023), Mylan/Viatris (31 July 2023), Sandoz (30 September 2023), Momenta (20 November 2023), Pfizer (20 November 2023), Fresenius Kabi (30 September 2023), Samsung Bioepis/Merck (30 June 2023), Coherus (1 July 2023) and Boehringer Ingelheim (1 July 2023).

China’s NMPA accepts BLA for Boan Biotech’s biosimilar to Amgen’s Xgeva® (denosumab)

Luye Pharma Group announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) accepted the BLA submitted by Luye’s subsidiary Boan Biotech for  denosumab (BA1102), biosimilar to Amgen’s Xgeva®. It is indicated for the treatment of bone metastases from solid tumors and patients with multiple myeloma, to delay or reduce the risk of skeletal-related events, and for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

In late 2022, Boan Biotech previously announced the apprA approval and launch of its Boyoubei® (denosumab, biosimilar to Amgen’s Prolia®), for the treatment of postmenopausal women with osteoporosis with high risk of fractures.

BioBlast w/e 17 Mar 23: Alvotech ustekinumab | Samsung Bioepis’ ustekinumab | Humira® US Medicare Rebates | Apotex aflibercept IPR | J&J US$25M Remicade® settlement | Lantus® price cut | Samsung Biologics US$1.5B plant … and more

Significant biosimilar activities this week include:

01 March 2023 | CA | Study finds nonmedical switching policy did not negatively impact patients

A new study published in Gastroenterology Research and Practice has found that British Columbia’s 2019 ‘Biosimilars Initiative’ was not associated with harmful impacts on medications and health services use.  The Initiative required IBD patients to switch from Johnson & Johnson’s Remicade® to an infliximab biosimilar (Pfizer’s Inflectra® or Organon’s Renflexis®).

06 March 2023 | No difference between rituximab biosimilars & Roche’s MabThera®, study says

A study published in BioDrugs found that there was no difference between rituximab biosimilars (Truxima® (Teva Pharmaceuticals), Rixathon® (Sandoz) and Ruxience® (Pfizer)) and the originator product (Roche’s MabThera®) for hypersensitivity reactions (at initiation, switch or over time).  The authors used data of 91,894 patients from the French National Health Data System over a five year period.  Further, no association was found between a switch to biosimilars and occurrence of hospitalization for anaphylactic shock or serum sickness after treatment.

This study comes after Dr Reddy’s also recently announced that it has successfully completed the full set of clinical studies of DRL_RI (proposed rituximab biosimilar) for filing in the US, EU and other regions.

10 March 23 | US | PTAB denies institution of Apotex’s IPR challenge to Regeneron key aflibercept patent

PTAB denied institution of the IPR filed by Apotex against Regeneron’s 11,253,572 patent relating to a method of treating an angiogenic eye disorder by administering a VEGF antagonist, including Eylea® (aflibercept).  Apotex filed the IPR in September 2022, challenging claims 1-5, 8-11, 14 and 26 for anticipation and 6, 7, 12 and 13 for obviousness.  PTAB found that Apotex had not demonstrated a reasonable likelihood that it would prevail in showing that any of the challenged claims of the ‘572 patent is unpatentable.

The ‘572 patent is one of the 24 patents included in the Regeneron suit against Mylan in West Virginia, filed in August 2022, and one of the six patents chosen by Regeneron to be determined at a 10 day trial in June 2023, 10 months after Regeneron filed its complaint.  No other application for IPR has been filed to date against the ‘572 patent, although there are currently 7 other applications against 3 patents pending: 10,130,681 (filed by Mylan, Celltrion and Samsung Bioepis), 10,888,601 (filed by Mylan, Celltrion and Samsung Bioepis) and 10,464,992 (filed by Celltrion).  Institution of Mylan’s challenge to 10,857,205 was recently denied after Regeneron disclaimed all claims of the patent. Last year PTAB invalidated Regeneron’s 9,254,338 and 9,669,069 for anticipation based on Mylan’s application for IPR.

In December 2022, we reported on Ontario’s biosimilar switching program which required patients to be transitioned to biosimilars (including infliximab) by 29 December 2023.

13 March 2023 | CN | Boan Biotech Ph III enrolment for BA9101 (proposed aflibercept biosimilar)

Luye Pharma Group announced that it has completed patient enrolment in Ph III trials of BA9101 (also known as OT-702), biosimilar to Regeneron’s aflibercept/Eylea®.  BA9101 was developed by Luye Pharma’s subsidiary Boan Biotech with clinical studies being conducted in conjunction with Boan’s partner Ocumension Therapeutics under an agreement announced in October 2020.

14 March 2023 | US | IN | Lupin share price increase after FDA inspection

Lupin Ltd announced that the FDA completed an inspection of its Bioresearch Centre in Pune, India, which was closed without any observation.  The Lupin share price increased by 1.4% on the day of the announcement. 

15 March 2023 | US | AbbVie’s Humira® (adalimumab) subject to US Medicare rebates

The US Department of Health and Human Services and the White House have announced that AbbVie will be required to pay rebates to the Centers for Medicare & Medicaid Services for raising the price of Humira® (adalimumab) faster than inflation.  This new mechanism was brought about by the Inflation Reduction Act 2022 through the Medicare Prescription Drug Inflation Rebate Program.  This new inflation rebate applies to Medicare Part B rebatable drugs: single source drugs, biological products and certain biosimilars.

15 March 2023 | US | J&J’s US$25M class action settlement in Remicade® (infliximab) antitrust lawsuit

The US District Court for Eastern Pennsylvania has made final orders to approve a US$25M settlement in the anti-trust class action lawsuit against Johnson & Johnson (J&J) and Janssen Biotech Inc relating to the supply of Remicade® (infliximab) between 5 April 2016 and 28 February 2022.  The Court also issued a Memorandum on Motion for Final Approval, finding that the Plaintiffs’ Motion for Final Approval of Settlement was appropriate.

The matter related to a class action alleging that J&J and Janssen engaged in anticompetitive conduct related to the supply of Remicade® in violation of federal and state antitrust laws and state consumer protection laws.  The action alleged that the two companies sought to block competition by new entrants in the infliximab market.

In July 2021, Pfizer and Johnson & Johnson settled antitrust litigation arising from the terms of J&J’s payer contracts which restricted reimbursement for Pfizer’s Inflectra® except if Remicade® was first proven ineffective for any particular patient.

16 March 2023 | US | Sanofi cuts price of Lantus® by 78%

Sanofi announced that it will cut the list price of its Lantus® insulin by 78% and establish a US$35 cap on OOP costs for patients with commercial insurance, with effect from 1 January 2024.  This is in addition to Winthrop’s (a Sanofi company) launch of its unbranded Lantus® biologic (insulin glargine U-100) in June 2022, which is 60% cheaper than the Lantus® product.

17 March 2023 | Alvotech data supports comparability of ATV04 (ustekinumab) with J&J’s Stelara®

Alvotech announced clinical studies support biosimilarity and comparability of its ATV04 (ustekinumab biosimilar) and Johnson & Johnson’s Stelara®.  The data will be presented at the American Academy of Dermatology Annual Meeting on 17-21 March in New Orleans.

EMA accepted Alvotech’s MAA for AVT04 in February 2023, and the FDA accepted a BLA for AVT04 in January 2023.

17 March 2023 | SK | Samsung Biologics 5th plant at second campus with 180,000L capacity

Samsung Biologics announced that it will commence construction of its fifth plant and its second Bio Campus to meet increased market demand.  Samsung Biologics will invest KRW 1.9T (~US$1.5B) to build the new facility with a 180,000L manufacturing capacity, bringing its total capacity to 784,000L.  It is expected that the site will commence operations in 2025.  Plant 4 started partial operations in October 2022 and is expected to commence full operations by mid-2023.

This announcement comes only weeks after Pfizer and Samsung Biologics entered into US$183M biologics CMO agreement.

17 March 2023 | Samsung data supports comparability of SB17 (ustekinumab) with J&J’s Stelara®

Samsung announced that its Phase I clinical studies for SB17, biosimilar to Stelara® (ustekinumab), demonstrated pharmacokinetic bioequivalence and comparable safety, tolerability, and immunogenicity to reference ustekinumab in healthy volunteers.   Samsung will present these results at the 2023 American Academy of Dermatology (AAD) Annual Meeting held in New Orleans, March 17-21, 2023.


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Naomi is recognised as one of Australia’s leading patent lawyers in virtually every notable legal guide and directory. Naomi is also Lawyers Weekly Women in Law Partner of the Year (SME Law) for 2021, and the Founding Principal of Pearce IP, which was recognised as the IP Team of the Year in the Australian Law Awards in December 2021.

Underpinning Naomi’s legal work is a deep understanding of the pharma/biopharma industries, resulting from 25 years’ experience including as VP of IP in-house at global pharma giants, Partner of a top-tier international law firm, and as the founding Principal of Pearce IP.

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Associate Lawyer

Sian is a driven intellectual property associate with a background in molecular genetics and experience in both private practice and within State Government. Sian’s experience working in medical research and advanced therapeutics policy supports Pearce IP’s clients on policy issues relating to the regulation of pharmaceutical/biopharmaceutical products in Australia.

Nailed It – the Full Federal Court upholds purposive construction of fuel cell claims

A central tenet of patent interpretation under Australian law is that the specification should be a given a purposive construction rather than a purely literal one.  While this is different to the Doctrine of Equivalents that exists in other jurisdictions, a purposive construction can result in a claim defining an invention being interpreted in a way that extends its scope beyond the literal meaning of the words employed at drafting.

Handing down the first Australian intellectual property judgment of 2023, the Full Federal Court in Airco Fasteners Pty Ltd v Illinois Tool Works Inc [2023] FCAFC 7 has dismissed Airco Fasteners Pty Ltd’s (Airco’s) appeal and affirmed the purposive claim construction of primary judge Justice Rofe.

Key takeaways

The Full Court confirmed that:

  • The Court can take into account appropriate, functional considerations when construing the specification in the context of constructing a claim
  • Dependant claims can be used to assist in the construction of independent claims
  • Key words repeated throughout a patent specification can be interpreted sensitive to context
  • The Court must determine the construction of patent claims, aided by expert evidence, however that opinion evidence does not supplant the Court’s role

Background

The Illinois Tool Works Inc (Illinois) patent in question related to an in-can fuel cell metering valve, primarily used in combustion tools such as nail guns. The invention includes “an internally mounted metering valve arranged such that a measured dose of fuel is dispensed each time the stem is pressed into the “open” position”.[1]

Illinois brought patent infringement proceedings against Airco who were importing, supplying and selling combustion tool fuel cells in Australia.

At first instance, Justice Rofe undertook an extensive construction analysis of the claims, and held that Airco’s combustion tool fuel cells had infringed Illinois’ patent.[2]

Airco’s Appeal

Airco appealed to the Full Federal Court arguing that Justice Rofe erred in her construction of Illinois’ patent claims. The two primary issues before the Court were whether the Airco products had, as her Honour found:

  • “a fuel metering chamber disposed in close proximity to said closure” (close proximity integer); and
  • “a valve body having a second end opposite said fuel metering chamber located within said container” (second end opposite integer).[3]

Concerning the close proximity integer, Airco argued that her Honour’s construction failed to give effect to the natural meaning of “close proximity” as emphasising the requirement of closeness, rather than simply proximity. Airco submitted that this was contrary to the expert evidence.[4]  Further, Airco argued that because claim 1 mandated that the fuel metering chamber was within the valve body, a fuel metering chamber located in that part of the body furthest from the closure could not be characterised as being in “close proximity” to the closure.

Airco submitted that the second end opposite integer ought to have been construed to require the fuel metering chamber be located at the other (ie “opposite”) end of the valve body to the “second end” of the valve body and outside (not “within”) the fuel container. The appellant also argued that the construction adopted by the primary judge involved construing the word “opposite” to have different meanings in the same document.

The Full Court Decision

Justices Rares, Moshinsky and Burley unanimously dismissed the appeal and upheld the decision of Justice Rofe.

The Full Court agreed that the phrase “close proximity” is used to describe the disposition of the fuel metering chamber relative to the closure in the context of the fuel cell as a whole. The Full Court affirmed that considering functionality was appropriate to construction, finding that “the fuel metering chamber does not need to be positioned adjacent to, or as close as possible to, the closure in order for the internal valve fuel cell of the invention to be configured in a manner that operates more efficiently and effectively than the fuel cells described in the prior art incorporated by reference into the Patent. The words “in close proximity” do not require this.”[5]

Interestingly, the Full Court also relied on dependent claims 3 and 7 of the patent to aid in construction of claim 1, albeit acknowledging that claim 7 provided a weaker support for the construction.

The Full Court highlighted that there is nuance in the construction of a word in different contexts within a specification. Their Honours found that “the word ‘opposite’ is sensitive to context”, and Justice Rofe’s construction of the term did not involve construing the word to have “different meanings” throughout the specification.[6]

Finally, the Full Court rejected Airco’s criticism that Justice Rofe, to some extent, construed the claims contrary to the evidence of both parties’ experts. Their Honours held that “it is for the Court to determine the meaning of the language of the claims, aided by the evidence of experts to assist in understanding unfamiliar terms and the technical context of the subject matter”, and that “expert opinion does not supplant the judicial role”.[7]

Conclusion

The Full Court has reaffirmed some key principles of patent construction, and has highlighted that the judicial role to construct patent claims cannot be usurped by expert evidence. It will be interesting to see whether these key issues will be expanded upon in future cases, and particularly how terms may be construed ‘sensitive to context’ throughout a specification.

At a practical level, for businesses and inventors seeking to obtain or enforce patents, this decision underscores the usefulness of carefully drafting and reviewing patent specifications to ensure that key terms and phrases are clearly defined and contextualised to support a broader interpretation of the claims.


[1] Airco Fasteners Pty Ltd v Illinois Tool Works Inc [2023] FCAFC 7 at [7].
[2] Illinois Tool Works Inc v Airco Fasteners Pty Ltd [2022] FCA 495 at [249].
[3] Airco Fasteners Pty Ltd v Illinois Tool Works Inc [2023] FCAFC 7 at [4].
[4] Ibid at [37].
[5] Ibid at [55].
[6] Ibid at [65].
[7] Ibid at [59].

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Sian Hope

Sian Hope

Associate Lawyer

Sian is a driven intellectual property associate with a background in molecular genetics and experience in both private practice and within State Government. Sian’s experience working in medical research and advanced therapeutics policy supports Pearce IP’s clients on policy issues relating to the regulation of pharmaceutical/biopharmaceutical products in Australia.

Samsung Biologics 5th plant at second campus with 180,000L capacity

Samsung Biologics announced that it will commence construction of its fifth plant and its second Bio Campus to meet increased market demand.  Samsung Biologics will invest KRW 1.9T (~US$1.5B) to build the new facility with a 180,000L manufacturing capacity, bringing its total capacity to 784,000L.  It is expected that the site will commence operations in 2025.  Plant 4 started partial operations in October 2022 and is expected to commence full operations by mid-2023.

This announcement comes only weeks after Pfizer and Samsung Biologics entered into US$183M biologics CMO agreement.

Janssen’s redacted public brief in support of preliminary injunction regarding Amgen’s Stelara® (ustekinemab) biosimilar

Janssen Biotech, Inc. has filed a redacted, public version of its opening brief in support of its motion for a preliminary injunction in proceedings relating to Amgen’s Stelara® (ustekinemab) biosimilar.  Janssen is seeking to enjoin Amgen, Inc. from manufacturing and using in commercial quantities, offering to sell, selling within the United States, or importing for commercial purposes into the United States its ABP 654 biosimilar product.  We previously reported that Janssen initially asserted two patents: US Patent Nos 6,902,734 (API) and 10,961,307 (methods of treating ulcerative colitis).  In its redacted brief Janssen states that while it has also asserted four ‘manufacturing’ patents, it is seeking a preliminary injunction for the duration of the proceedings based on only two of these: US Patent Nos 9217168 and 9475858.  We also previously reported that Janssen refiled its preliminary injunction motion after its original motion was denied because it did not comply with the court’s page limit requirements.

J&J’s US$25M class action settlement in Remicade® (infliximab) antitrust lawsuit

The US District Court for Eastern Pennsylvania has made final orders to approve a US$25M settlement in the anti-trust class action lawsuit against Johnson & Johnson (J&J) and Janssen Biotech Inc relating to the supply of Remicade® (infliximab) between 5 April 2016 and 28 February 2022.  The Court also issued a Memorandum on Motion for Final Approval, finding that the Plaintiffs’ Motion for Final Approval of Settlement was appropriate.

The matter related to a class action alleging that J&J and Janssen engaged in anticompetitive conduct related to the supply of Remicade® in violation of federal and state antitrust laws and state consumer protection laws.  The action alleged that the two companies sought to block competition by new entrants in the infliximab market.

In July 2021, Pfizer and Johnson & Johnson settled antitrust litigation arising from the terms of J&J’s payer contracts which restricted reimbursement for Pfizer’s Inflectra® except if Remicade® was first proven ineffective for any particular patient.

AbbVie’s Humira® (adalimumab) subject to US Medicare rebates

The US Department of Health and Human Services and the White House have announced that AbbVie will be required to pay rebates to the Centers for Medicare & Medicaid Services for raising the price of Humira® (adalimumab) faster than inflation. This new mechanism was brought about by the Inflation Reduction Act 2022 through the Medicare Prescription Drug Inflation Rebate Program.  This new inflation rebate applies to Medicare Part B rebatable drugs: single source drugs, biological products and certain biosimilars.

VHA announces coverage of LEQEMBI™ (lecanemab) for veterans living with early Alzheimer’s disease

The Veterans’ Health Administration (VHA) announced coverage of Esai’s LEQEMBI™ (lecanemab) for veterans with early stages of Alzheimer’s disease (AD), two months after the FDA approved LEQEMBI™ under the Accelerated Approval Pathway.  This Pathway requires Eisai to continue phase IV testing to confirm its clinical benefit, and therapies under this pathway are not fully covered by the Centers for Medicare & Medicaid Services.

We reported on 5 March 2023 that the FDA accepted Eisai/Biogen’s sBLA and granted priority review for traditional approval of LEQEMBI™ for treatment of AD. On 27 February 2023 the companies announced that LEQEMBI™ was designated for Priority Review by the NMPA in China.

BioBlast w/e 10 Mar 23: MiGenTra African developed Humira biosim | USD$400M Sandoz biosim facility | Celltrion fourth aflibercept IPR | Celltrion Remsima SC® | Coherus Udenyca® US approval | Genentech sues Biogen & Millennium for Cabilly royalties | Jannsen Amgen Stelara® dispute …

Significant biosimilar activities this week include:

09 March 2023 | EU | Sandoz signs MOU for USD$400M biologics facility  

Novartis announced that Sandoz signed an MOU to build a new biologics production facility in Lendava, Slovenia.  The investment is expected to be worth at least USD$400M and is one of the largest international private sector investments in Slovenia.  Work on the new plant is set to begin in 2023, with full operations provisionally planned for late 2026. 

This comes only a few weeks after Roche’s Genentech announced it is investing US$280M to build a new biologics manufacturing facility in Oceanside California that will begin operations in 2025. 

07 March 2023 | Research report claims that global biologics and biosimilars market likely to increase US$271.5B by 2028 

An Extrapolate Research report estimates that the biologics and biosimilars market is likely to upsurge by US$271.5 billion globally by 2028.  The report claims that monoclonal antibodies dominate the market.  

06 March 2023 | MiGenTra phase I German trial for first African developed mAb – biosimilar adalimumab 

MiGenTra, a German healthcare transforming company, announced the commencement of the German phase I trial of Minapharm Pharmaceuticals’ African developed adalimumab biosimilar (Adessia®) on 24 February 2023.  Results are expected at the end of 2023.   

MiGenTra was founded in 2021 by ProBioGen (CMDO) and Minapharm Pharmaceuticals with management in Berlin and Cairo, to develop biosimilars, cell and gene therapies and vaccines.  MiGenTra and Minapharm Pharmaceuticals are jointly responsible for filing and commercialising Adessia® in Africa and the Middle East.  

06 March 2023 | US | Jannsen re-files motion for preliminary injunction regarding Amgen’s ustekinumab biosimilar  

Jannsen Biotech, Inc. has filed another motion for a preliminary injunction against Amgen regarding its ustekinemab biosimilar, after its original motion was denied by US District Court Judge Noreika on 2 March 2023.  Jannsen is seeking to enjoin Amgen, Inc. from manufacturing and using in commercial quantities, offering to sell, selling within the United States, or importing for commercial purposes into the United States its ABP 654 biosimilar product. 

As we previously reported, Judge Noreika had denied Jannsen’s motion because it did not comply with the court’s page limit requirements.  Her Honour orally ordered that the motion could be re-filed in compliance with court requirements. 

06 March 2023 | US | FDA approves Coherus Udenyca® pegfilgrastim biosimilar 

Coherus announced that the FDA has approved its single-dose, prefilled autoinjector presentation of Udenyca® (pegfilgrastim-cbqv) biosimilar to Amgen’s pegfilgrastim (Neulasta®) as an additional presentation on 3 March 2023.  This the only US approved PFS presentation of pegfilgrastim.   

05 March 2023 | US | FDA grants priority review for Biogen & Eisai’s LEQEMBI™ lecanemab  

Biogen and Eisai Co announced that the FDA has accepted their sBLA and has granted priority review for traditional approval of LEQEMBI™ (lecanemab) for treatment of Alzheimer’s disease.  It was approved under the Accelerated Approval Pathway on 6 January 2023 (approval based on ‘surrogate’ marker or endpoint). 

On 27 February 2023 the companies announced that LEQEMBI™ was designated for Priority Review by the NMPA in China. 

04 March 2023 | Long term data demonstrates Janssen’s Stelara® (ustekinumab) safety and efficacy 

Janssen announced its positive long-term safety and clinical data for Stelara® (ustekinumab) in Chron’s disease and ulcerative colitis (five and four years respectively) at the ECCO Congress.  The findings indicate that key safety events were similar between a placebo and Stelara®.  The data demonstrated that of the patients with moderate to severe ulcerative colitis who achieved clinical response and continued treatment with Stelara® for 200 weeks – 58% were in clinical remission and 80% were in clinical response.  

03 March 2023 | Celltrion positive phase III results for infliximab biobetter Remsima SC® 

Celltrion Healthcare presented its positive phase III results for its infliximab biobetter Remsima SC® as a sub-cutaneous maintenance therapy for patients with IBD.  Remsima SC® (CT-P13 SC) is Celltrion’s subcutaneous re-formulation of Johnson & Johnson’s infliximab (Remicade®).  

Celltrion’s ABLA for Remsima SC® was filed with FDA on 22 December 2022 for use in ulcerative colitis  and Crohn’s disease.  Remsima SC® has been approved in several other jurisdictions (Europe, Korea and Canada) for treatment of various inflammatory conditions.  

02 March 2023 | US | FDA and FTC seek to advance biologic marketplace competition 

The FDA provided an update on its collaboration with the Federal Trade Commission (FTC) which it announced in February 2020.  The FDA and FTC have been working together on issues including exchanging information about how to combat anti-competitive activities and those that harm public health.  The two agencies have developed an educational resource for consumers about biosimilars to address common community misconceptions. 

01 March 2023 | US | Regeneron disclaims US 10,857,205 (relating to Regeneron’s Eylea®) 

PTAB denied institution of Mylan’s IPR challenge to US10,857,205 (relating to Regeneron’s Eylea® aflibercept), after Regeneron filed a disclaimer with the USPTO, disclaiming all claims of the patent.   

28 February 2023 | US | Genentech sues Biogen & Millennium for breach of Cabilly licence  

Genentech has filed separate complaints against Biogen (in the US District Court Northern District of California) and Millennium (in the Superior Court of State of California) alleging breach of their respective licences to the Cabilly patents.  The Cabilly patents related to methods of manufacturing antibodies, and was one of the most widely licensed patent families in the biotechnology industry.  The last of the US pre-GATT filed “submarine” patents counterparts expired on 18 December 2018. 

The Complaint against Millennium (23-CIV-00924) alleges that Millennium’s Entyvio® (vedolizumab) product was manufactured in accordance with the Cabilly patents and royalties were paid to Genentech until the Cabilly patent expired.  Genentech argue that Millennium’s stockpile of Entyvio® which was manufactured before the Cabilly patents expired, but would be sold after 18 December 2018, constituted a “licenced product” and royalties are owed based on the sales of those products.  

The Complaint against Biogen (3:23-cv-909) is similar, but pertains to Biogen’s Tysabri® (natalizumab) product.  Genentech allege that Biogen also owe royalties based on sales of Tysabri® that were manufactured before the Cabilly patents expired but sold after.   

Genentech is unaware of the size of Millennium and Biogen’s respective stockpiles, but claims that they each owe Genentech “tens of millions of dollars in unpaid royalties”. 

28 February 2023 | US | Celltrion fourth IPR for Regeneron (aflibercept) patent 

Celltrion filed an application for inter-partes review (IPR) against a fourth Regeneron US patent 10,406,226 relating to a method of making a VEGF antagonist fusion protein, including the fusion protein aflibercept supplied by Regeneron as Eylea®.    

Celltrion previously filed IPRs against Regeneron’s method of treatment patents 10,888,601 and 10,130,681 patents on 10 February 2023, as did Viatris (Mylan) on 11 January 2023 and Samsung Bioepis on 10 February 2023 and 6 January 2023 respectively.  Last month Celltrion and Samsung Bioepis separately sought joinder of their challenges to Regeneron’s ’601 and ’681 patents with Viatris’ IPR against the ‘601 and ‘681 patents, which were instituted in January 2023 

The Regeneron suit against Mylan in West Virginia, filed in August 2022, includes each of the ‘601, ‘681 and ‘226 patents.  The ‘601 patent is one of the six patents chosen by Regeneron to be determined at a 10 day trial in June 2023, 10 months after Regeneron filed its complaint.  


Pearce IP offers Australian based, life sciences focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance.  Call us today on 02 9023 9988 or email info@pearceIP.law.

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Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer, Patent & Trade Mark Attorney

Naomi is recognised as one of Australia’s leading patent lawyers in virtually every notable legal guide and directory. Naomi is also Lawyers Weekly Women in Law Partner of the Year (SME Law) for 2021, and the Founding Principal of Pearce IP, which was recognised as the IP Team of the Year in the Australian Law Awards in December 2021.

Underpinning Naomi’s legal work is a deep understanding of the pharma/biopharma industries, resulting from 25 years’ experience including as VP of IP in-house at global pharma giants, Partner of a top-tier international law firm, and as the founding Principal of Pearce IP.

Sian Hope

Sian Hope

Associate Lawyer

Sian is a driven intellectual property associate with a background in molecular genetics and experience in both private practice and within State Government. Sian’s experience working in medical research and advanced therapeutics policy supports Pearce IP’s clients on policy issues relating to the regulation of pharmaceutical/biopharmaceutical products in Australia.

PTAB denies institution of Apotex’s IPR challenge to Regeneron key aflibercept patent

PTAB denied institution of the IPR filed by Apotex against Regeneron’s 11,253,572 patent relating to a method of treating an angiogenic eye disorder by administering a VEGF antagonist, including Eylea® (aflibercept).  Apotex filed the IPR in September 2022, challenging claims 1-5, 8-11, 14 and 26 for anticipation and 6, 7, 12 and 13 for obviousness.  PTAB found that Apotex had not demonstrated a reasonable likelihood that it would prevail in showing that any of the challenged claims of the ‘572 patent is unpatentable.

The ‘572 patent is one of the 24 patents included in the Regeneron suit against Mylan in West Virginia, filed in August 2022, and one of the six patents chosen by Regeneron to be determined at a 10 day trial in June 2023, 10 months after Regeneron filed its complaint.  No other application for IPR has been filed to date against the ‘572 patent, although there are currently 7 other applications against 3 patents pending: 10,130,681 (filed by Mylan, Celltrion and Samsung Bioepis), 10,888,601 (filed by Mylan, Celltrion and Samsung Bioepis) and 10,464,992 (filed by Celltrion).  Institution of Mylan’s challenge to 10,857,205 was recently denied after Regeneron disclaimed all claims of the patent. Last year PTAB invalidated Regeneron’s 9,254,338 and 9,669,069 for anticipation based on Mylan’s application for IPR.

In December 2022, we reported on Ontario’s biosimilar switching program which required patients to be transitioned to biosimilars (including infliximab) by 29 December 2023.

Sandoz signs MOU for USD$400M biologics facility

Novartis announced that Sandoz signed an MOU to build a new biologics production facility in Lendava, Slovenia.  The investment is expected to be worth at least USD$400M and is one of the largest international private sector investments in Slovenia.  Work on the new plant is set to begin in 2023, with full operations provisionally planned for late 2026. 

This comes only a few weeks after Roche’s Genentech announced it is investing US$280M to build a new biologics manufacturing facility in Oceanside California that will begin operations in 2025. 

International Women’s Day | Eliza Jane Saunders on women in law

March 8 is International Women’s Day, a day where we together recognise the unique challenges women face around the world and seek to advance gender equality and the rights of women in a positive, respectful way.

Pearce IP has a female founder and more than 80% of its leaders across the firm are women.  It is a place where it is “normal” to see women in leadership and where pay equity is a ‘given’. We are proud to have a majority leadership of capable, respected women, which is rarely seen in law firms in Australia. Pearce IP also has a celebrated female workforce of above 80%.

In honour of International Women’s Day, we asked Pearce IP’s Executive Lawyer, Patent and Trade Mark Attorney, Eliza Jane Saunders about her experience as a woman in law, and her journey to Executive. Quadruply qualified as a lawyer, patent attorney, trade mark attorney, and molecular biologist, and with over 20 years of legal practice, Eliza discusses the challenges she has overcome, influences in her life and advice she would give to young women considering a career in law.

Who were the most significant female role models in your life?

The most significant female influence in my life, including the best piece of advice I ever received, came from my mother.  Despite having a very high IQ my mother was not given the opportunity to have a good education and pursue a career.  She therefore instilled in me how lucky I was to have such opportunities.  She always said, “it doesn’t matter what you choose to do, be the best at it and you will succeed”.  It was based on this influence that I focussed myself on pursuing a career in an area of law that I was really interested in, life sciences intellectual property.  Irrespective of career, I encourage all girls, and women to choose a career in a field where you have added natural abilities, whether it is technical skills, artistic qualities, public speaking skills etc.  By following this advice, being the best you possibly can be in that field will come naturally.

Pearce IP is refreshingly different for me as when I first commenced practice as a lawyer, I faced a myriad of challenges that my male counterparts did not.  While some aspects of the workplace have improved for women over time, barriers still exist and I am passionate about seeing them removed and all women being provided with equal opportunity.

20 years ago, it was not easy for women to have a successful career and a family.  Most successful women I knew and worked with in law and in the patent attorney profession did not have children.  When I started my family 14 years ago, there was no paid maternity leave and the perception was that your career would suffer.  But, you not only lose traction in your career, returning to the workplace is also challenging. Today, parental leave it is far more acceptable and encouraged with most firms providing both mothers and fathers with paid parental leave.  But we can still do better when reintroducing women back to the workplace after parental leave to ensure they feel both supported and enabled to succeed.

Another challenge for women within a law environment has traditionally been that women are generally more gentle, kind and compassionate than men and don’t “sell” themselves as well. I think this is changing as society has become more appreciative of authenticity and the value of women in all workplaces.

There have also been advances over the past 20 years with technology, and with that, transparency, which has created a more equal playing field for women.

I have overcome every challenge thrown at me in the workplace by running my own race, not comparing myself to others, being grateful for the opportunities I have had and valuing my own worth.

What makes Pearce IP refreshingly different to the firms that made it hard for women to thrive?

Pearce IP has associated with it none of the stereotypes that can arise in the vast majority of law firms. First, the founder, Naomi Pearce is a dedicated mother and to that extent represents a more realistic humane and nurturing approach. Second, although an ultra-perfectionist herself, Naomi builds up her staff, focussing on all their positive attributes and successes rather than getting bogged down in any unrealistic negative. Thirdly, Pearce IP is not just a firm for women but is equally balanced in many respects, making for a wonderfully diverse working environment.

Looking to the future, what lessons do you want to pass on to the next generation of female lawyers?

As a leader and a mother, I encourage all women to pursue whatever career they are passionate about.  It is like falling in love, you know it when you see it and you will know there is no other career you wish to pursue.  If there is a particular field of law you dream of, focus on that, study more about it, look for and pursue as many opportunities as possible as you can obtain in that field, and last of all, do not give up.  You will face rejection and setbacks at times as standards are incredibly high in the legal profession.  Like in any career, perseverance and determination will result in a very rewarding career.

Surround yourself with good people, be driven to be the best at what you do and celebrate your successes, always.


Pearce IP’s founder Naomi Pearce is the 2022 Asia Pacific Patent Lawyer of the Year at the Women in Business Law Awards, is the only Australian practitioner recognised by WIPR as a Diversity Champion in IP for 2022, and the only Australian practitioner honoured by WIPR Diversity in 2021 in the world’s top 100 Influential Women in IP.  Naomi was honoured to be the recipient of the peer reviewed Lawyers Weekly Women in Law Partner of the Year (SME Law) in 2021.  Pearce IP was also one of 5 firms shortlisted for the jurisdiction award for Australia at the 2022  Women in Business Law Awards, an award which celebrates “law firms that have developed strong innovative practices and projects that highlight gender diversity”.

Pearce IP’s founder and CEO, Naomi Pearce says:

“I am incredibly proud of our dedicated lawyers and attorneys who are thriving in the Pearce IP “work from anywhere” business model.
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The challenges faced by women facing a career in law are significant, and may appear overwhelming at times, but the fact that 80% of Pearce IP’s leaders are women is testament to the fact that in the right environment, women in law can thrive.
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Today, on International Women’s Day, I celebrate Pearce IP’s diversity, and honour and congratulate our female leaders Eliza Jane Saunders, Jacinta Flattery O’Brien and Adele Chadwick and their teams for all they have endured and overcome, and all they have achieved professionally and personally throughout.”

About Pearce IP

​Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the pharmaceutical, biopharmaceutical and life sciences industries. 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. Pearce IP leaders are well recognised as leading IP practitioners.

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, Women in Law Awards – Partner of the Year, Best Lawyers and Australasian Lawyer 5 Star Awards, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Learn more about how Pearce IP demonstrates, promotes and leads diversity in the workplace.

FDA accepts sBLA for Sanofi/Regeneron Dupixent® (dupilumab)

Sanofi and Regeneron announced that the FDA has accepted their sBLA for Dupixent® (dupilumab) to treat chronic spontaneous urticaria.  The FDA’s decision is expected on 22 October 2023.  The sBLA relied on data from two phase III trials (LIBERTY-CUPID Studies A and B). 

Sanofi also recently announced that it received EC approval for Dupixent® as the first and only targeted medicine indicated for eosinophilic esophagitis in the EU.  

BioBlast w/e 03 March 23: BioBlast w/e 03 March 23: Enzene adalimumab launch | Biocon CRL | Celltrion & GeneMedicine trastuzumab deal | Alvotech 2022 results | Celltrion & Samsung Bioepis seek to join Mylan aflibercept IPR | Pfizer/Samsung Biologics manufacturing agreement | Janssen ustekinemab proceedings against Amgen | Celltrion founder returns | Biogen CA ranibizumab biosimilar approved

Significant biosimilar activities this week include:

28 February 2023 | IN | Enzene Biosciences begins supply of Humira® (adalimumab) biosimilar in India  

Biospectrum India reported that Enzene Biosciences has launched its adalimumab (biosimilar to AbbVie’s Humira®) in India for the treatment of ankylosis spondylitis and rheumatoid arthritis.  Enzene believes that this is the first commercial launch using continuous manufacturing technology, which will reduce COGS.  This is the fourth biosimilar launch for Enzene, following teriparatide (treatment for osteoporosis) approval on 4 February 2021, romiplostim (treatment for chronic Immune Thrombocytopenic Purpura) on 10 August 2021, and denosumab (treatment for osteoporosis) on 27 August 2021.

10 Feb 2023 | US | Celltrion & Samsung Bioepis seek to join Mylan aflibercept IPR (Regeneron) 

Celltrion and Samsung Bioepis each filed motions seeking joinder of their respective IPR challenges to Regeneron’s 10,888,601 patent for Eylea® (aflibercept) with Mylan’s, which was instituted in January 2023.

PTAB also instituted Mylan’s IPR against Regeneron’s US10,130,681.   A third Mylan IPR challenge against US10,857,205 remains pending and is likely to be initiated in April 2023.

Separately, Regeneron sued Mylan in West Virginia in August 2022, alleging infringement of 24 patents relating to Eylea (including the ‘601 patent), and a 10 day trial has been set down for June 2023, which is 10 months after Regeneron filed its complaint.

12 February 2023 | US | FDA issue CRL to Biocon Biologics regarding bevacizumab biosimilar

Biocon Biologics announced that the FDA has issued a Complete Response Letter for the bevacizumab application for bevacizumab, filed by Viatris (Mylan).  The letter required resolution of FDA observations following the FDA inspection of Biocon’s facility in August 2022.  Biocon is “confident” of a timely resolution to the FDA concerns.

Biocon completed a multi-billion dollar acquisition of Viatris’ biosimilar assets business in December 2022.

27 February 2023 | Celltrion signs R&D deal with GeneMedicine to develop trastuzumab biosimilar 

Korean Biomed has reported that Celltrion has entered into a joint R&D contract with GeneMedicine, a Korean anticancer virus development company, to develop CT-P6, biosimilar to Genentech’s Herceptin® (trastuzumab), in system administration form.  Celltrion will provide the raw material and GeneMedicine will apply its proprietary nanomaterial-based platform technology (that enables effective and tumor-targeted systemic administration of oncolytic viruses).  The companies plan to develop platform technology with the goal of completing the non-clinical parts of the development by the end of 2023.

01 March 2023 | US | Alvotech announce 2022 financial results  

Alvotech announced its full financial results for 2022, highlighting its annual revenue increased by 114% to USD$85M, primarily driven by the commercialisation of AVT02 (adalimumab), biosimilar to AbbVie’s Humira® in 17 countries.  As of December 31, 2022, the company had cash and cash equivalents of US$66.4 million, and R&D expenses were US$180.6 million.  In addition, Alvotech highlighted recent corporate achievements, including its marketing applications for AVT04  (ustekinumab), a proposed biosimilar to Johnson & Johnson’s Stelara® in the US (FDA accepted BLA for review in January 2023 with a new goal date of 13 April 2023), and EU (expected EMA recommendation in the second half of 2023).

The company held a business update conference with the investment community on 2 March 2022.

Robert Wessman, Chairman and CEO of Alvotech said that “Looking ahead, 2023 is expected to be equally important.  We’re currently preparing for a reinspection of our Reykjavik facility by the FDA, which, if satisfactory, could pave the way for the approval and subsequent launch of our interchangeable, high concentration biosimilar to Humira® in the US market on July 1, 2023.”

02 March 2023 | SK | Pfizer and Samsung Biologics enter into US$183M manufacturing agreement 

Samsung revealed in a South Korean regulatory filing that it has entered into a KRW$241 billion (~USD$183M) contract with Pfizer. The ‘Biologics CMO Contract’ is effective between 28 February 2023 and 31 December 2029 and relates to the manufacture of unnamed biologics by Samsung Biologics on behalf of Pfizer.

02 March 2023 | US | Janssen’s motion for preliminary injunction regarding Amgen’s ustekinemab biosimilar denied by District Court

On Thursday, US District Court Judge Noreika denied a motion filed by Janssen Biotech, Inc (a Johnson & Johnson subsdiary) for a preliminary injunction regarding Amgen’s ustekinemab biosimilar, because the motion did not comply with the court’s page limit requirements.  We previously reported that Janssen commenced proceedings against Amgen in the US District Court (District of Delaware) in November 2022, asserting infringement of two patents, US 6902734 (ustekinemab compound) and US 10961307 (use of ustekinemab for the treatment of ulcerative colitis).   Judge Noreika ordered that the motion may be refiled in compliance with court requirements, so the consequences of the denial may be short-lived.   Janssen’s original Complaint states that Amgen had notified Janssen of its intention to commence marketing its Stelara® biosimilar on 6 May 2023 or as soon as it received FDA approval thereafter.

01 March 2023 | AU | November PBAC Meeting outcomes list four biologics  

The November 2022 PBAC meeting has recommended the following biologics for PBS listing:

  • Sanofi-Aventis’ dupilumab (Dupixent®) autoinjectors in two new forms for the same indications as the currently listed pre-filled syringe, to treat chronic severe atopic dermatitis and uncontrolled severe asthma in patients aged 12 years and older.
  • Merck’s pembrolizumab (Keytruda®) for the treatment of persistent, recurrent, or metastatic (Stage IVB) squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma of the cervix in patients whose tumours express PD-L1 combined positive score equal to or greater than 1. This is further to pre-existing listing for unresectable Stage III or Stage IV malignant melanoma, resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma, relapsed or refractory Hodgkin lymphoma, Stage IV (metastatic) non-small cell lung cancer, locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer, relapsed or refractory primary mediastinal B-cell lymphoma, unresectable or metastatic deficient mismatch repair colorectal cancer and recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx.
  • Pfizer’s pneumococcal polysaccharide conjugate vaccine, for the prevention of pneumococcal disease in individuals with an at-risk condition (≥ 18 years), non-Indigenous adults aged ≥ 70 years and Aboriginal and Torres Strait Islander adults aged ≥ 25 years. This was the first submission of the vaccine for the proposed vaccination populations.
  • AbbVie’s risankizumab (Skyrizi®) (which was on the July 2022 PBAC meeting agenda but a decision was deferred to November 2022) to treat adults with severe Crohn’s disease, who have failed to achieve an adequate response, or are contraindicated, to prior systemic therapy, further to pre-existing listing for treatment for severe chronic plaque psoriasis

03 March 2023 | US | Retired Celltrion founder and chairman returns to management 

The Korea Biomedical Review has reported that Seo Jung-jin, founder and the honorary chairman of Celltrion Group, who left the company in March 2021, has been asked to return to management. He was asked to return to assist Celltrion’s reorganisation of future strategies given the instability of the global economy. Appointment of Seo will be finalised at the upcoming shareholders’ meeting on 28 March.

02 March 2023 | CA | Biogen announces ranibizumab biosimilar Byooviz™ approved

Biogen announced that its ranibizumab biosimilar Byooviz™to Genentech’s Lucentis® is available in Canada following approval by Health Canada for treatment of serious eye disorders including neovascular (wet) age-related macular degeneration. On 2 June 2022, Byooviz™ was launched in the US.

BioBlast® Editor and Contributing Author

Naomi Pearce & Sian Hope

Naomi Pearce & Sian Hope

Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Sian Hope, Associate Lawyer

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