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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 25 Nov 22: AbbVie’s risankizumab, FDA investigating Prolia® (denosumab) risk, Amneal’s filgrastim launch, Junshi Biosciences’ adalimumab, US biosimilars bill, Teva and Sandoz biosimilars ramp-up

Significant biosimilar activities this week include:

23 Nov 22 | EU | EMA approves Skyrizi® (risankizumab) for Crohn’s disease

AbbVie announced that Skyrizi® (risankizumab) has been approved for the additional indication of Crohn’s disease by EMA.  This is the first specific interleukin-23 inhibitor to be approved for Crohn’s disease.

22 Nov 22 | US | FDA investigating risk of Prolia® (denosumab) in advanced kidney disease

The FDA announced that it is investigating the risk of severe hypocalcemia with serious outcomes in patients with advanced kidney disease on dialysis treated with Amgen’s Prolia® (denosumab).  According to the announcement, FDA’s review of interim results of ongoing safety studies suggested an increased risk of hypocalcemia in patients with advanced kidney disease, and a substantial risk with serious outcomes including hospitalization and death.

22 Nov 22 | US | Amneal launches Releuko® (biosimilar filgrastim) in the US

Amneal announced the launch of Releuko® (biosimilar filgrastim) for the treatment of neutropenia. Amneal and Amgen settled their patent dispute in November 2019.  This is the second biosimilar product to be launched by Amneal this year, following the US launch of Alymsys® (biosimilar bevacizumab) in October 2022.

22 Nov 22 | CN | Junshi Biosciences obtains additional indications for 君邁康® (biosimilar adalimumab) in China

Junshi Biosciences announced today that China’s NMPA has approved its supplemental application for additional indications for 君邁康® (biosimilar adalimumab) for the treatment of Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, plaque psoriasis in children and Crohn’s disease in children.

22 Nov 22 | Biosimilars boom is upon us, as Teva and Sandoz plan biosimilars ramp-up

Reuters reported that Teva and Sandoz are planning a significant ramp-up in production of biosimilars.

According to Reuters:

  • More than 55 blockbuster biologics will come off patent protection over the next decade, and account for more than $270 billion in expected peak annual sales;.
  • The value of the global biosimilar market could more than triple to an estimated $74 billion by 2030.
  • Sandoz is currently the second biggest player after Pfizer in the biosimilar market by gross sales globally. Amgen is in third place).
  • Sandoz has launched eight biosimilar drugs, has 15 products in development, and in the next five years would like to double the value of its marketed portfolio
  • Teva has 3 approved biosimilars and 13 in development.
  • EMA has approved more than 50 biosimilars, and biosimilars have taken the majority of market share from brand-name biologics in Europe and resulted in savings between 75% to 90% off the reference product prices.
  • FDA has approved 39 biosimilars and 22 products have been launched as of October 2022.

22 Nov 22 | US | Merck Announces positive results from Phase 3 trial of KEYTRUDA® (pembrolizumab) combined with chemotherapy in gastric cancer

Merck announced positive results from the Phase 3 KEYNOTE-859 trial investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. Merck reported that the treatment showed significant and clinically meaningful improvement in the trial’s primary endpoint of overall survival (OS), and that significant and clinically meaningful improvement in progression-free survival (PFS) and overall response rate (ORR) were also observed.  Keytruda is already approved by the FDA and elsewhere for other gastric and GEJ tumours.

17 Nov 22 | US | New biosimilars bill aims to remove interchangeable requirement for pharmacy substiution

Senator Mike Lee (R-UT) introduced the Biosimilars Red Tape Elimination Bill into the US Senate, which – if implemented, will prohibit the FDA from requiring biosimilars to undergo switching studies to obtain ‘interchangeable’ designation.  Unlike small-molecule drugs, biosimilars cannot be substituted at the pharmacy level without this interchangeability designation.

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.

Merck Announces positive results from Phase 3 trial of KEYTRUDA® (pembrolizumab) combined with chemotherapy in gastric cancer

Merck announced positive results from the Phase 3 KEYNOTE-859 trial investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. Merck reported that the treatment showed significant and clinically meaningful improvement in the trial’s primary endpoint of overall survival (OS), and that significant and clinically meaningful improvement in progression-free survival (PFS) and overall response rate (ORR) were also observed.  Keytruda is already approved by the FDA and elsewhere for other gastric and GEJ tumours.

Biosimilars boom is upon us, as Teva and Sandoz plan biosimilars ramp-up

Reuters reported that Teva and Sandoz are planning a significant ramp-up in production of biosimilars.

According to Reuters:

  • More than 55 blockbuster biologics will come off patent protection over the next decade, and account for more than $270 billion in expected peak annual sales;.
  • The value of the global biosimilar market could more than triple to an estimated $74 billion by 2030.
  • Sandoz is currently the second biggest player after Pfizer in the biosimilar market by gross sales globally. Amgen is in third place).
  • Sandoz has launched eight biosimilar drugs, has 15 products in development, and in the next five years would like to double the value of its marketed portfolio
  • Teva has 3 approved biosimilars and 13 in development.
  • EMA has approved more than 50 biosimilars, and biosimilars have taken the majority of market share from brand-name biologics in Europe and resulted in savings between 75% to 90% off the reference product prices.
  • FDA has approved 39 biosimilars and 22 products have been launched as of October 2022.

FDA investigating risk of Prolia® (denosumab) in advanced kidney disease

The FDA announced that it is investigating the risk of severe hypocalcemia with serious outcomes in patients with advanced kidney disease on dialysis treated with Amgen’s Prolia® (denosumab).  According to the announcement, FDA’s review of interim results of ongoing safety studies suggested an increased risk of hypocalcemia in patients with advanced kidney disease, and a substantial risk with serious outcomes including hospitalization and death.

BioBlast w/e 18 Nov 22: Eli Lilly’s interchangeable insulin glargine, Organon trastuzumab and bevacizumab launches, Biocon Viatris’ biosimilar asset acquisition, Janssen guselkumab study, NICE Keytruda® recommendation, Stelis’ teriparatide

Significant biosimilar activities this week include:

18 Nov 22 | US | FDA approves Rezvoglar® (biosimilar insulin glargine) as interchangeable

The FDA approved Eli Lilly’s Rezvoglar® (biosimilar insulin glargine) as an interchangeable biosimilar to Lantus®.  Rezvoglar was approved as a biosimilar in December 2021.

18 Nov 22 | KR | Celltrion obtains second approval for Yuflyma® (biosimilar adalimumab)

Korea Biomedical Review reported that Celltrion has obtained approval from South Korea’s Ministry of Food and Drug Safety for a domestically manufactured Yuflyma® (biosimilar adalimumab).

17 Nov 22 | Dong-A ST completes Ph III trials of DMB-3115 (ustekinumab biosimilar)

Korea Biomedical Review reported that Dong-A ST has completed Ph III trials of DMB-3115 (biosimilar ustekinumab).  Dong-A ST reported that it plans to file for regulatory approval in the US and Europe in the first half of 2023.  DMB-3115 has been jointly developed by Dong-A ST and Meiji Seika Pharma.  Intas Pharma and Meiji/Dong-A ST signed a commercialisation agreement in July 2021 for DMB-3115.

16 Nov 22 | Alvotech publishes financial results for the first nine months of 2022

Alvotech reported its financial results for the first nine months of 2022, reporting revenue of $59.2 million compared to $2.0 million for the same period in 2021.  Alvotech also announced financing facilities securing gross proceeds of approximately $136 million.

14 Nov 22 | CA | Organon launches trastuzumab and bevacizumab biosimilars in Canada

Organon launched Ontruzant® (biosimilar trastuzumab) and Aybintio® (biosimilar bevacizumab) in Canada. Ontruzant and Aybintio were developed and manufactured by Samsung Bioepis, under a February 2013 agreement.

14 Nov 22 | Biocon announces financial results for Q2 2022

Biocon announced its financial results for Q2 2022, reporting consolidated revenue growth of 23% year on year.  Biocon’s acquisition of Viatris’ global biosimilars business is expected to close “soon”.  Biocon announced that it would acquire Viatris’ biosimilar assets for USD 3.335 billion in stock and cash in February 2022.

14 Nov 22 | Alvotech announces Australian approval for AVT02 (biosimilar adalimumab)

Alvotech announced the Australian approval for AVT02 (biosimilar adalimumab).  Cipla will supply Alvotech’s product in Australia and New Zealand under a partnership first announced in July 2019 for adalimumab, which was expanded in March 2021 to include 4 additional biosimilars: aflibercept, ustekinumab, denosumab and golimumab biosimilars.

14 Nov 22 | EU | Stelis Biopharma obtains positive CHMP opinion for Kauliv™ (biosimilar teraparatide)

Strides’ biologics arm Stelis Biopharma announced that it has obtained a positive CHMP recommendation for its first biosimilar product Kauliv™ (teriparatide, biosimilar to Eli Lily’s Forsteo®) for the treatment of osteoporosis.

Kualiv is the first biosimilar product developed in house by Stelis.  Stelis will make Kualiv, which it has already licensed across 20 countries, in Bangalore.  According to the announcement, the product “will generate incremental revenues for the Company starting FY24”.

Stelis is developing teriparatide, insulin glargine (biosimilar to Sanofi’s Lantus®), insulin lispro (biosimilar to Eli-Lilly’s Humalog®), insulin aspart (biosimilar to NovoNordisk’s Novolog®) and another “recently filed peptide for diabetes”.

11 Nov 22 | Janssen publishes Ph III results of Tremfya® (guselkumab) for psoriatic arthritis

Janssen published data from Ph III trials of Tremfya® (guselkumab) for the treatment of psoriatic arthritis.  Janssen reported that early skin and enthesitis responses predicted longer-term clinical response, including disease remission at week 52.

08 Nov 22 | UK | NICE recommends Keytruda® (pembrolizumab) for triple-negative breast cancer

NICE published final draft guidance recommending Keytruda® (pembrolizumab) for the treatment of triple-negative breast cancer.  NICE expects to publish its final guidance on pembrolizumab for treating early or locally advanced triple-negative breast cancer next month (December 2022).

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.

Naomi Pearce is 2022 Lexology Client Choice Award Winner for Life Sciences

Pearce IP congratulates its CEO, Executive Lawyer, Patent Attorney and Trade Mark Attorney Naomi Pearce for being the exclusive winner of the 2022 Lexology Client Choice Award for Life Sciences.

Naomi is one of 18 Client Choice winners in Australia, and the only Australian lawyer/attorney recognised in the life sciences category which is highly competitive.  Client Choice recognised 651 winners across 70 jurisdictions worldwide.

Client Choice is a client driven award.  Corporate counsel are asked to rate individuals on quality of advice, commercial awareness, industry knowledge, strategic thinking, billing transparency, tailored fee structures, value for money, responsiveness, effective communication, clarity of documentation, sharing of expertise, appropriate staffing, project management, use of technology, loyalty and ethics.

Lexology reports the following comments made by corporate counsel about Naomi:

“Naomi is a first-class advisor in the field of pharmaceutical law, bringing together technical knowledge, regulatory experience and a huge depth of knowledge of patent law.”

 

“The size and strength of Naomi’s team and the quality of the clients and matters speaks volumes.”

 

“Naomi Pearce is a multiple-award winning principal and an inspiration to her team and to other lawyers.”

 

“Naomi has a co-operative and enquiring approach, making working with her both stimulating and enjoyable, whilst ensuring the best possible outcomes.”

Pearce IP Special Counsel Jacinta Flattery-O’Brien PhD says:

“Naomi is an outstanding example of an IP lawyer who hones in on her clients’ needs and delivers in spades.  Her success in developing a multi-award-winning full service IP firm specialising in pharmaceuticals and life sciences was achieved in record time due, in no small measure, to Naomi’s legendary relentless pursuit of excellence.”

We also congratulate Katrina Howard SC for being the only Australian barrister to receive the Client Choice Award for Life Sciences.

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 has been shortlisted as a finalist for the ‘Intellectual Property Team of the Year’ in the 2022 Lawyers Weekly Australian Law Awards.  Pearce IP was crowned the ‘Intellectual Property Team of the Year’ in the 2021 Lawyers Weekly Australian Law Awards, and the firm is ranked in IAM Patent 1000 for both patent services and in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm.  Pearce IP leaders are well recognised as leading IP practitioners.  Team members 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 – Patent Stars & Notable Practitioner, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Women in Law Awards – Partner of the Year, Best Lawyers and Australasian Lawyer 5 Star Awards.

Client Choice Award

Established in 2005, Client Choice recognises those individuals around the world that stand apart for the excellent client care they provide and the quality of their service. The criteria for this recognition focus on an ability to add real value to clients’ business above and beyond the other players in the market. Uniquely, lawyers can be nominated only by corporate counsel, with this year’s winners chosen from a pool of more than 2,000 individual client assessments.

Client Choice Methodology

To ensure that the results cannot be influenced, law firms are not informed when this initial round of research is conducted.  The results of this survey are used to draw up shortlists by country and work area, and shortlisted candidates are then invited to submit up to five client referees. The research team conducts follow-up interviews and additional research where necessary.

Naomi Pearce

Naomi Pearce

Executive Lawyer, Patent Attorney & 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.

Jacinta Flattery-O'Brien PhD

Jacinta Flattery-O'Brien PhD

Special Counsel, Patent Attorney

Jacinta is a trusted and recognised leader in biotech/pharma patenting, identified as an "IP Star" by the highly regarded Managing Intellectual Property Journal (MIP) for her expertise.

She is a registered patent attorney with 20 years' experience serving clients in the biotechnology, pharmaceutical and biopharmaceutical industries.

Dong-A ST completes Ph III trials of DMB-3115 (ustekinumab biosimilar)

Korea Biomedical Review reported that Dong-A ST has completed Ph III trials of DMB-3115 (biosimilar ustekinumab).  Dong-A ST reported that it plans to file for regulatory approval in the US and Europe in the first half of 2023.  DMB-3115 has been jointly developed by Dong-A ST and Meiji Seika Pharma.  Intas Pharma and Meiji/Dong-A ST signed a commercialisation agreement in July 2021 for DMB-3115.

BioBlast w/e 11 Nov 22: Dupixent® recommended by CHMP, TME Pharma’s NOX-A12, World first denosumab biosimilar approved, Alvotech’s adalimumab IC data, Mylan’s IPR win against Regeneron aflibercept patents, MHRA biosimilars guidance, Amgen biosimilars data, Coherus’ ranibizumab

Significant biosimilar activities this week include:

11 Nov 22 | EU | CHMP recommends Dupixent® (dupilimab) for prurigo nodularis

The CHMP recommended the approval of Dupixent® (dupilumab) for the treatment of moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

11 Nov 22 | TME Pharma publishes data from Ph I/II trials of NOX-A12 with radiotherapy and bevacizumab

TME Pharma announced the publication of interim data from Ph I/II clinical trials of NOX-A12 (PEGylated L-stereoisomer RNA aptamer that targets CXCL12) combined with radiotherapy and bevacizumab biosimilar in first-line MGMT unmethylated brain cancer.  A poster presentation containing additional and updated data will be presented at the Society for Neuro-Oncology Annual Meeting on 18 November 2022.

10 Nov 22 | CN | First global denosumab biosimilar approved in PRC for Luye Pharma/Boan Biotech

China’s NMPA approved Luye Pharma subsidiary Boan Biotech’s Boyoubei® (denosumab biosimilar) for the treatment of postmenopausal women with osteoporosis at high risk of fractures.  Boyoubei® is the first biosimilar to Prolia® (the originator of denosumab) approved for marketing anywhere in the world.  Boan Biotech is developing Boyoubei for global sale.

10 Nov 22 | Alvotech to present data from adalimumab IC switching studies

Alvotech announced that it will present two posters (and will be featured in an Ignite Talk) related to its switching study for ATV02 (100mg/mL citrate-free biosimilar adalimumab) at the American College of Rheumatology (ACR) Convergence Conference, in Philadelphia on November 10-14, 2022.  Alvotech is the only known company that has both developed a high-concentration biosimilar candidate to Humira and completed a switching study to support potential regulatory approval as an interchangeable product.  Alvotech’s application for AVT02 was accepted in February 2022.

09 Nov 22 | US | PTAB invalidates two Regeneron aflibercept patents

PTAB issued decisions in Mylan’s IPR challenges relating to Regeneron’s 9,254,338 and 9,669,069 relating to Eylea® (aflibercept),  invalidating all claims the subject of the Mylan challenge, for anticipation.  Mylan’s IPRs were heard by PTAB in August 2022.  Regeneron filed a complaint against Mylan in West Virginia on 03 August 2022, alleging infringement of twenty-four patents – including the 2 subject patents – relating to Eylea® (aflibercept).

08 Nov 22 | US | Coherus’ Cimerli™ (biosimilar ranibizumab) achieves leading biosimilar market share in the US

Coherus Biosciences provided a business update, announcing that Cimerli™ (biosimilar ranibizumab) has achieved leading biosimilar market share in the US within the first four weeks of launch, with 2023 net sales expected to exceed $100 million.  Coherus’ net revenue for the quarter ending September 2022 was $45.4 million, down from $82.5 million for the quarter ending September 2022.  Coherus attributed this decline to a decrease in the sales of Udencya® (pegfilgrastim biosimilar) as well as a lower net realized price due to increased competition.

07 Nov 22 | Amgen to present data on biosimilars portfolio at ACRC

Amgen announced that it will present data across its portfolio at the American College of Rheumatology Convergence on 10-14 November 2022, including data for Amgevita® (biosimilar adalimumab), Enbrel® (biosimilar etanercept) and Prolia® (biosimilar denosumab).

07 Nov 22 | UK | MHRA updates 2021 biosimilars guidance

The MHRA has updated its guidance on the licensing of biosimilars to allow interchangeability between biosimilars to the same reference product at the prescriber level.  The MHRA’s position on pharmacy substitution (not allowed) remains unchanged.  This follows a similar move by the EMA in September 2022.

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.

Stelis Biopharma obtains positive CHMP opinion for Kauliv™ (biosimilar teraparatide)

Strides’ biologics arm Stelis Biopharma announced that it has obtained a positive CHMP recommendation for its first biosimilar product Kauliv™ (teriparatide, biosimilar to Eli Lily’s Forsteo®) for the treatment of osteoporosis.

Kualiv is the first biosimilar product developed in house by Stelis.  Stelis will make Kualiv, which it has already licensed across 20 countries, in Bangalore.  According to the announcement, the product “will generate incremental revenues for the Company starting FY24”.

Stelis is developing teriparatide, insulin glargine (biosimilar to Sanofi’s Lantus®), insulin lispro (biosimilar to Eli-Lilly’s Humalog®), insulin aspart (biosimilar to NovoNordisk’s Novolog®) and another “recently filed peptide for diabetes”.

Biocon announces financial results for Q2 2022

Biocon announced its financial results for Q2 2022, reporting consolidated revenue growth of 23% year on year.  Biocon’s acquisition of Viatris’ global biosimilars business is expected to close “soon”.  Biocon announced that it would acquire Viatris’ biosimilar assets for USD 3.335 billion in stock and cash in February 2022.

TME Pharma publishes data from Ph I/II trials of NOX-A12 with radiotherapy and bevacizumab

TME Pharma announced the publication of interim data from Ph I/II clinical trials of NOX-A12 (PEGylated L-stereoisomer RNA aptamer that targets CXCL12) combined with radiotherapy and bevacizumab biosimilar in first-line MGMT unmethylated brain cancer.  A poster presentation containing additional and updated data will be presented at the Society for Neuro-Oncology Annual Meeting on 18 November 2022.

Alvotech to present data from adalimumab IC switching studies

Alvotech announced that it will present two posters (and will be featured in an Ignite Talk) related to its switching study for ATV02 (100mg/mL citrate-free biosimilar adalimumab) at the American College of Rheumatology (ACR) Convergence Conference, in Philadelphia on November 10-14, 2022.  Alvotech is the only known company that has both developed a high-concentration biosimilar candidate to Humira and completed a switching study to support potential regulatory approval as an interchangeable product.  Alvotech’s application for AVT02 was accepted in February 2022.

First global denosumab biosimilar approved in PRC for Luye Pharma/Boan Biotech

China’s NMPA approved Luye Pharma subsidiary Boan Biotech’s Boyoubei® (denosumab biosimilar) for the treatment of postmenopausal women with osteoporosis at high risk of fractures.  Boyoubei® is the first biosimilar to Prolia® (the originator of denosumab) approved for marketing anywhere in the world.  Boan Biotech is developing Boyoubei for global sale.

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Dwyer

Naomi Pearce & Emily Dwyer

Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Emily Dwyer, Graduate Lawyer, Trainee Trade Mark Attorney

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