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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 12 November 2021

Nov 16, 2021

09 Nov 21 | Coherus BioSciences reported its Q3 2021 financial results. Coherus announced that FDA review of CHS-201 (proposed adalimumab biosimilar) is advancing towards the target action date in December 2021. Coherus also disclosed that the FDA has accepted the BLA for its proposed toripalimab biosimilar for advanced nasopharyngeal carcinoma, with a target action date of April 2022.

10 Nov 21 | Celltrion announced its Q3 2021 financial results. Celltrion reported that Remsima® (infliximab biosimilar) has obtained a 53% market share in Europe and 21% market share in Japan. Celltrion reported that Truxima® (rituximab biosimilar) has obtained a 40% market share in Europe and Herzuma® (trastuzumab biosimilar) has obtained a 14% market share in Europe. Celltrion also reported that it expects to launch biosimilar bevacizumab in 2022, biosimilar ustekinumab in 2023, biosimilar omalizumab and aflibercept in 2024 and biosimilar denosumab in 2025.

12 Nov 21 | EU | The CHMP recommended approval of Celltrion’s regdanvimab for the treatment of adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

12 Nov 21 | RegenXBio announced additional interim data from its Ph II trials of RGX-314 (proposed one-time gene therapy for the treatment of wet age-related macular degeneration, diabetic retinopathy and other chronic retinal diseases). RGX-314 is a recombinant adeno-associated virus (AAV) gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein.

12 Nov 21 | AU | AU’s PBAC published the outcomes from its July 2021 meeting. PBAC recommended listing:

Pfizer’s Abrilada® (50mg/mL adalimumab biosimilar) in 20mg/0.4mL syringe, 40mg/0.8mL syringe and 40mg/0.8mL pen for all indications as Humira®.
Janssen’s Darzalex SC® (daratumumab) for all indications for which the intravenous form of daratumumab is currently listed.
Pfizer’s Enbrel® (etanercept) in 50mg/1mL single use dose-dispenser cartridges under the same conditions as existing listings for etanercept.
BMS’ Opdivo® (nivolumab) for the treatment of patients with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression following treatment with a fluoropyrimidine and platinum (FP)-based chemotherapy regimen.

Pearce IP offers Australian based, generics and biosimilars 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.

EC approves Regkirona® (regdanvimab, CT-P59) for adults with COVID-19

Nov 15, 2021

Celltrion announced that the EC has approved Regkirona® (regdanvimab, CT-P59) for adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

AU’s PBAC publishes the outcomes from its July 2021 meeting

Nov 12, 2021

AU’s PBAC published the outcomes from its July 2021 meeting. PBAC recommended listing:

Pfizer’s Abrilada® (50mg/mL adalimumab biosimilar) in 20mg/0.4mL syringe, 40mg/0.8mL syringe and 40mg/0.8mL pen for all indications as Humira®.
Janssen’s Darzalex SC® (daratumumab) for all indications for which the intravenous form of daratumumab is currently listed.
Pfizer’s Enbrel® (etanercept) in 50mg/1mL single use dose-dispenser cartridges under the same conditions as existing listings for etanercept.
BMS’ Opdivo® (nivolumab) for the treatment of patients with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression following treatment with a fluoropyrimidine and platinum (FP)-based chemotherapy regimen.

RegenXBio announces additional interim data from Ph II trials of RGX-314

Nov 12, 2021

RegenXBio announced additional interim data from its Ph II trials of RGX-314 (proposed one-time gene therapy for the treatment of wet age-related macular degeneration, diabetic retinopathy and other chronic retinal diseases). RGX-314 is a recombinant adeno-associated virus (AAV) gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein.

CHMP recommends Celltrion’s Regkirona® regdanvimab for COVID-19

Nov 12, 2021

The CHMP recommended approval of Celltrion’s Regkirona® regdanvimab for the treatment of adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

Celltrion provides update on biosimilars pipeline

Nov 10, 2021

Celltrion announced its Q3 2021 financial results. Celltrion reported that Remsima® (infliximab biosimilar) has obtained a 53% market share in Europe and 21% market share in Japan. Celltrion reported that Truxima® (rituximab biosimilar) has obtained a 40% market share in Europe and Herzuma® (trastuzumab biosimilar) has obtained a 14% market share in Europe. Celltrion also reported that it expects to launch biosimilar bevacizumab in 2022, biosimilar ustekinumab in 2023, biosimilar omalizumab and aflibercept in 2024 and biosimilar denosumab in 2025.

FDA review of CHS-201 (proposed adalimumab biosimilar) advancing towards the target action date in December 2021

Nov 9, 2021

Coherus BioSciences reported its Q3 2021 financial results. Coherus announced that FDA review of CHS-201 (proposed adalimumab biosimilar) is advancing towards the target action date in December 2021. Coherus also disclosed that the FDA has accepted the BLA for its proposed toripalimab biosimilar for advanced nasopharyngeal carcinoma, with a target action date of April 2022.

Pearce IP BioBlast®: w/e 05 November 2021

Nov 8, 2021

01 Nov 21 | The International Generic and Biosimilar Medicines Association called on all stakeholders ahead of its second Global Biosimilars Week to join the Biosimilars Movement on Advancing Access. The campaign seeks to gather useful ideas, experience, information and resources for and from patients, doctors and all other stakeholders across the healthcare community.

02 Nov 21 | Pfizer released its Q3 2021 results, reporting a 34% increase operationally in biosimilars. Pfizer announced that it plans to launch citrate-free Abrilada® (biosimilar adalimumab) in the US as early as 1 July 2023 in accordance with its agreement with AbbVie. Pfizer disclosed that it plans to seek interchangeable status for Abrilada® in December 2021.

02 Nov 21 | Fresenius Kabi released its Q3 2021 financial results. Fresenius Kabi confirmed that despite delays due to COVID-19, it expects to launch its pegfilgrastim biosimilar candidate in the EU in 2022.

03 Nov 21 | US | Pharmacy benefit manager Prime Therapeutics announced that it will add Semglee® (interchangeable biosimilar insulin glargine) to its preferred national formularies.

04 Nov 21 | Novartis announced that it will sell its stake in Roche for a total of USD 20.7 billion, stating that it no longer views its financial stake in Roche as part of its core business. This follows the announcement by Novartis that it would undertake a strategic review of the Sandoz division.

PTE Alert: Recent cases create fertile ground for PTE challenges

Nov 5, 2021

In the last year, two significant Federal Court decisions, reported here and here have exposed key flaws in the Australian Patent Office’s interpretation of the eligibility requirements for a patent term extension (PTE). In September 2021, another PTE challenge was filed in response to an infringement suit.

These cases highlight the importance of thoroughly analysing PTE eligibility at the time of submitting a PTE request or when considering the validity of patents and their applicable term. Equally, they serve as a reminder to patentees that prudent portfolio strategy can head off potential issues, and that review of existing patents may be necessary to prevent possible challenges.

Australia’s PTE system – the basics

Australia’s PTE scheme offers extensions of term of up to five years on patents that cover approved pharmaceutical substances. In order to be eligible for a PTE, the patent must disclose and claim one or more pharmaceutical substances per se, or disclose and claim one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology. Additionally, at least one of these substances must be listed on the Australian Register of Therapeutic Goods (ARTG). Importantly, the PTE application must be based on the ‘first regulatory approval date’ of a pharmaceutical substance, and at least five years must have elapsed between the effective filing date of the patent application and this first regulatory approval date.

Unlike the SPC system in Europe, a PTE extends the term of the patent as a whole and will therefore extend the patent protection for all pharmaceutical substances claimed in the patent. However, exploiting a form of the claimed invention other than the claimed pharmaceutical substance per se during the extension period will not infringe the rights of the patentee. The same holds true for the use of the claimed pharmaceutical substance for purposes other than therapeutic use.

Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643 – competitor products cannot form the basis of a PTE application

Under section 70 of the Patents Act a PTE application is based on the inclusion in the ARTG of goods containing, or consisting of, a relevant pharmaceutical substance within the relevant time period. The provision does not expressly limit such goods to those of the patentee. Thus, the Patent Office has traditionally taken the approach that the inclusion of competitor goods on the ARTG containing or consisting of a patented substance will trigger the time period for a PTE application, and that such an application can only be made in respect of those goods. The Ono case, which we reported in detail here, concerned such a situation. The patent-in-suit, Australian Patent No. 2011203119 covers antibodies that bind the immune checkpoint inhibitor PD-1. Both Opdivo® (patentee’s product) and Keytruda® (a competitor’s product) fell within the scope of the claims. Initially, the Patent Office found that the registration of Keytruda® could be considered the ‘earliest first regulatory approval’, and therefore the patentee’s PTE application based on Opdivo® was refused. In June 2021, the Federal Court overturned this decision, finding that the PTE provisions were intended to compensate patentees for delays in obtaining regulatory approval and that a liberal construction should be adopted. This decision was appealed to the Full Court of the Federal Court and was heard in early November 2021.

Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2021] FCA 947 – PTE must be based on registration of first pharmaceutical substance where more than one substance is claimed in a single patent

As we previously reported, the decision in Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2021] FCA 947 dealt with s 77 of the Patents Act, and the interpretation of the phrase ‘earliest first regulatory approval date’. In this case, the patent-in-suit claimed two pharmaceutical substances: sitagliptin, and a composition containing a combination of sitagliptin and metformin. It was not disputed that these two substances were different pharmaceutical substances per se. The sitagliptin alone product obtained regulatory approval within 5 years of the patent date, and the combination product received regulatory approval 6 years after the patent date. As a result, the sitagliptin alone product was ineligible to form the basis of a PTE under
s 70(3) of the Patents Act.

Merck Sharp & Dohme (MSD) contended that it was entitled to rely on the later registration of the combination product as the basis for its PTE. Notably, the Patent Office granted this PTE even though MSD disclosed the earlier regulatory approval date of the sitagliptin alone product in its PTE application. The court found that the PTE application must be based on the earliest first approval date of any of the pharmaceutical substances disclosed within the patent. As such, the approval date for the sitagliptin alone product was considered to be the ‘earliest first approval date’, rendering the patent ineligible for a PTE. This decision has been appealed and has been heard by the Full Court in early November 2021.

Biogen International GmbH & Anor v Pharmacor Pty Limited

Biogen commenced infringement proceedings against Pharmacor on 5 August 2021, alleging that Pharmacor’s recently approved dimethyl fumarate products infringed Australian Patent No. 2000011572 ‘Utilisation of dialkylfumarates’. The ’572 patent received a PTE in 2014 which extended the term of the patent by 5 years to 29 October 2024. On 20 September 2021, Pharmacor cross-claimed in the proceeding, challenging the validity of a number of claims and the validity of the PTE.

In particular, Pharmacor contends that the PTE application is not based on a pharmaceutical substance per se, as the basis of that application was a pharmaceutical preparation in the form of microtablets or micropellets. Additionally, Pharmacor contends that the complete specification of the patent only discloses the pharmaceutical preparation for use in specific indications, and therefore does not disclose a pharmaceutical substance per se.

Implications

Given the number of PTE challenges and appeals on foot, originators and generics alike should carefully monitor this space. As the approach of the Patent Office in relation to PTEs continues to be successfully challenged in the courts, the number of potentially invalid PTEs grows, creating fertile ground for PTE challenges as a further line of defence in patent infringement cases.

The evolving PTE jurisprudence also has crucial practical implications for patentees of pharmaceutical patents, particularly in relation to the breadth of the claims and the timing of PTE applications. For example, it is essential that patentees are aware of all the pharmaceutical substances covered by their claims and the relevant regulatory approval dates of these pharmaceutical substances. It is also critical that the review of issues relating to the PTE be undertaken well before the PTE deadline to allow for appropriate amendment of the claims, if necessary, in order to exclude (generally by a narrow proviso) products that might jeopardise the request, and to pursue additional pharmaceutical substances in one or more divisional applications. This will ensure that PTE requests are based on the relevant pharmaceutical substance and that the PTE request is filed within the required time.

The decisions of the Full Court of the Federal Court in the Ono and Merck v Sandoz cases may have a significant effect on the extent to which we continue to see such PTE challenges in the future and Pearce IP will, of course, keep you advised of developments.

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.

Novartis to sell stake in Roche

Nov 4, 2021

Novartis announced that it will sell its stake in Roche for a total of USD 20.7 billion, stating that it no longer views its financial stake in Roche as part of its core business. This follows the announcement by Novartis that it would undertake a strategic review of the Sandoz division.

Prime Therapeutics adds Semglee® (interchangeable biosimilar insulin glargine) to its preferred national formularies

Nov 3, 2021

Pharmacy benefit manager Prime Therapeutics announced that it will add Semglee® (interchangeable biosimilar insulin glargine) to its preferred national formularies.

Pearce IP BioBlast®: w/e 29 October 2021

Nov 2, 2021

22 Oct 21 | Biocon released its Q2 2022 financial results, reporting a 10% increase in biosimilars revenue year on year.

22 Oct 21 | Chugai Pharmaceutical announced that it will construct a new manufacturing facility in Tokyo to produce biopharmaceuticals for early clinical trials.

25 Oct 21 | Janssen announced data from two new analyses of Stelara® (ustekinumab) for the treatment of adults with Crohn’s disease and ulcerative colitis. Janssen reported that the data from these analyses provides additional support for Stelara® as a first-line option for Crohn’s disease and ulcerative colitis.

26 Oct 21 | Novartis disclosed in its Q3 2021 earnings announcement that it will undertake a strategic review of the Sandoz division. Novartis stated that this review will explore all options ranging from retaining the business to separation.

27 Oct 21 | Korea Biomedical Review announced that Samsung Bioepis has completed Ph III trials of SB12 (proposed eculizumab biosimilar) for the treatment of paroxysmal nocturnal hemoglobinuria.

27 Oct 21 | Teva released its Q3 2021 financial results, reporting a 2% decrease in revenues compared to Q3 2020. Teva disclosed that it does not expect to launch any new biosimilars in 2022.

Fresenius Kabi expecting to launch pegfilgrastim biosimilar in the EU in 2022

Nov 2, 2021

Fresenius Kabi released its Q3 2021 financial results. Fresenius Kabi confirmed that despite delays due to COVID-19, it expects to launch its pegfilgrastim biosimilar candidate in the EU in 2022.

Pfizer to launch citrate-free adalimumab in the US as early as 1 July 2023

Nov 2, 2021

Pfizer released its Q3 2021 results, reporting a 34% increase operationally in biosimilars. Pfizer announced that it plans to launch citrate-free Abrilada® (biosimilar adalimumab) in the US as early as 1 July 2023 in accordance with its agreement with AbbVie. Pfizer disclosed that it plans to seek interchangeable status for Abrilada® in December 2021.

IGBA calls on stakeholders ahead of Global Biosimilars Week

Nov 1, 2021

The International Generic and Biosimilar Medicines Association called on all stakeholders ahead of its second Global Biosimilars Week to join the Biosimilars Movement on Advancing Access. The campaign seeks to gather useful ideas, experience, information and resources for and from patients, doctors and all other stakeholders across the healthcare community.

Teva releases its Q3 2021 financial results

Oct 27, 2021

Teva released its Q3 2021 financial results, reporting a 2% decrease in revenues compared to Q3 2020. Teva disclosed that it does not expect to launch any new biosimilars in 2022.

Samsung Bioepis completes Ph III trials of SB12 (proposed eculizumab biosimilar) for the treatment of paroxysmal nocturnal hemoglobinuria

Oct 27, 2021

Korea Biomedical Review announced that Samsung Bioepis has completed Ph III trials of SB12 (proposed eculizumab biosimilar) for the treatment of paroxysmal nocturnal hemoglobinuria.

Novartis to conduct strategic review of Sandoz division

Oct 26, 2021

Novartis disclosed in its Q3 2021 earnings announcement that it will undertake a strategic review of the Sandoz division. Novartis stated that this review will explore all options ranging from retaining the business to separation.

Pearce IP BioBlast®: w/e 22 October 2021

Oct 26, 2021

14 Oct 21 | Gan & Lee Pharmaceuticals announced the completion of two Ph III studies of its proposed insulin glargine biosimilar.

15 Oct 21 | US | Roche announced that the FDA has approved Tecentriq® (atezolizumab) as adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Stage II-IIIA non-small cell lung cancer whose tumours express PD-L1≥1%.

16 Oct 21 | Bio-Thera Solutions announced it has reached a licensing and supply agreement with Pharmapark for BAT2206 (proposed ustekinumab biosimilar). Under the agreement, Pharmapark will have exclusive rights to distribute and market the product in Russia and other CIS countries.

18 Oct 21 | AU | Australia’s TGA provisionally approved Roche’s Ronapreve™ (casirivimab and imdevimab) for two indications relating to COVID-19. Ronapreve™ is indicated for the treatment of COVID-19 in adults and adolescents who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19, and for the prevention of COVID-19 in adults and adolescents who have been exposed to SARS-CoV-2 and who either have a medical condition making them unlikely to respond to or to be protected by vaccination or are not vaccinated against COVID-19.

19 Oct 21 | AU | Opthea announced that the first clinical trial sites in the Asia-Pacific region are now open for patient enrolment in its Ph III trials of OPT-302 (VEGF-C/-D ‘trap’ inhibitor).

20 Oct 21 | HepaRegeniX announced a new collaboration with the Netherlands Cancer Institute to investigate HRX-0233 (MKK4 inhibitor candidate) in preclinical in vivo models with Kirsten rat sarcoma virus (KRAS) mutant tumours.

20 Oct 21 | US | Samsung Bioepis announced that the FDA has approved Byooviz™ (ranibizumab biosimilar) for the treatment of neovascular age-related macular degeneration, macular edema and myopic choroidal neovascularisation.

20 Oct 21 | MorphoSys announced that the first patient has been dosed in its Ph II trials evaluating felzartamab for patients with Immunoglobulin A Nephropathy.

21 Oct 21 | US | Biocon announced that pharmacy benefit management company Express Scripts will list Semglee® (interchangeable biosimilar insulin glargine) as a preferred insulin brand on its National Preferred Formulary.

21 Oct 21 | AU | The NSW State Government pledged $96 million towards a RNA pilot manufacturing facility, to be established in partnership with NSW universities. The facility is expected to house laboratories and pre-clinical trial spaces to enable early-stage RNA-based drug development.

21 Oct 21 | CN | Kintor Pharmaceutical announced that China’s NMPA has approved clinical trials for GT90008 (PD-L1/TGF-β dual-targeting antibody) for the treatment of advanced solid tumours.

21 Oct 21 | EU | BMS announced that the EMA has approved Opdivo® (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC) whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5.

22 Oct 21 | US | Genentech announced that the FDA has approved Susvimo™ (ranibizumab) for intravitreal use via ocular implant for the treatment of patients with wet age-related macular degeneration who have previously responded to at least two anti-VEGF injections.

Janssen announced data from two new analyses of the use of Stelara® (ustekinumab) in Crohn’s disease and ulcerative colitis

Oct 25, 2021

Janssen announced data from two new analyses of Stelara® (ustekinumab) for the treatment of adults with Crohn’s disease and ulcerative colitis. Janssen reported that the data from these analyses provides additional support for Stelara® as a first-line option for Crohn’s disease and ulcerative colitis.

Chugai Pharma to construct a new manufacturing facility in Tokyo

Oct 22, 2021

Chugai Pharmaceutical announced that it will construct a new manufacturing facility in Tokyo to produce biopharmaceuticals for early clinical trials.

Biocon reports 10% increase in biosimilars revenue year on year

Oct 22, 2021

Biocon released its Q2 2022 financial results, reporting a 10% increase in biosimilars revenue from its subsidiary Biocon Biologics year on year.

FDA approves Susvimo™ (ranibizumab) for intravitreal use via ocular implant for the treatment of wet age-related macular degeneration

Oct 22, 2021

Genentech announced that the FDA has approved Susvimo™ (ranibizumab) for intravitreal use via ocular implant for the treatment of patients with wet age-related macular degeneration who have previously responded to at least two anti-VEGF injections.

EMA approves Opdivo® (nivolumab) for the first-line treatment of gastric, gastroesophageal junction or esophageal adenocarcinoma

Oct 21, 2021

BMS announced that the EMA has approved Opdivo® (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC) whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5.