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Insights+ Key Biosimilars Events of May 2022

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Insights+ Key Biosimilars Events of May 2022

Insights+ Key Biosimilars Events of May 2022

  • Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
  • Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients
  • During the month of May, JSR Life Sciences launches Similis Bio business division to accelerate biosimilar development, Viatris and Biocon launched Abevmy (biosimilar, bevacizumab) for the treatment of cancer in Canada Our team at PharmaShots has summarized 10 key events of the biosimilar space of May 2022

Coherus Terminates its License Agreement with Innovent for Byvasda (biosimilar, bevacizumab)

Published: May 06, 2022

Product: Byvasda (biosimilar, bevacizumab)

  • Coherus has terminated its license agreement with Innovent for Byvasda, a biosimilar referencing bevacizumab. Coherus will return the rights to Innovent
  • In Jan 2020, Coherus has entered into a license agreement with Innovent for Avastin biosimilar where Coherus got the development & commercialization rights of CHS-305 in the US & Canada
  • Byvasda has been approved in China for patients with lung & colorectal cancers in June 2020 while the NMPA has expanded the indication list for the biosimilar to include unresectable HCC when paired with sintilimab therapy in June 2021. The US FDA’s review of the BLA for Cimerli (biosimilar, ranibizumab) is expected to be completed by Aug 2, 2022

JSR Life Sciences Launches Similis Bio Business Division to Accelerate Biosimilar Development

Published: May 10, 2022

Product: N/A

  • The company launched its new business division, Similis Bio to improve efficiency & costs for biosimilar development by using the combined experience & technical knowledge of leaders in analytical, cell-line & process development
  • Similis will supply companies & offers analytical & process development data to determine an appropriate biosimilar target, accelerate early program development & reduce analytical costs
  • Similis Bio will foster co-development agreements with companies to develop biosimilar programs in which partners will get an exclusive right to purchase multiple programs. JSR designed Similis’ collaboration model is intended to reduce the risks of canceled programs and extend market analysis timelines

Henlius Entered into a License Agreement with Eurofarma for Three Biosimilar Products in Latin America

Published: May 11, 2022

Product: N/A

  • Henlius to receive a total value of ~$50.5M including a $4.5M up front. The companies collaborated to develop, manufacture, and commercialize Henlius' 3 products i.e., Hanlikang (rituximab, biosimilar), Hanquyou (trastuzumab, biosimilar) & Hanbeitai (bevacizumab biosimilar) in 16 Latin America countries
  • Eurofarma to acquire exclusive rights to Hanlikang in 12 countries, Hanquyou in 11 countries, and Hanbeitai in 15 countries including Mexico. Eurofarma will also obtain semi-exclusive rights in Brazil
  • This collaboration is a testament to Henlius' product quality, operational strength & continuance of Henlius’ goal of expanding its global footprint. Henlius & Farma de Colombia collaborated to promote Hanlikang's commercialization in Colombia, Peru, Ecuador & Venezuela

Pfizer Files Lawsuit to Halt Sales of Brenzys (biosimilar, etanercept) in Australia

Published: May 16, 2022

Product: Brenzys (biosimilar, etanercept)

  • Pfizer filed a new patent lawsuit against 5 companies (Samsung Bioepis, Merck, Sharp & Dohme, Organon, and Arrow) to stop the marketing of Brenzys, a biosimilar referencing etanercept in Australia. In the EU, Brenzys is marketed as Benepali
  • Pfizer gets the marketing rights for Amgen’s etanercept. Pfizer asserts that the respondents' claims about cell culture methods infringe on Australian patent no. 2005280034 titled "Production of polypeptides"
  • Pfizer & its subsidiary Hospira were prior involved in a patent dispute for biosimilars referencing Neupogen & Neulasta which are used to treat patients with FN who undergoes CT scan. Amgen & Pfizer have settled their agreement for filgrastim biosimilar in Sept 2021 & pegfilgrastim biosimilar for Mar 2021

Alvotech Reports Results of AVT04, a Proposed Biosimilar to Stelara in (AVT04-GL-101) PK Study for the Treatment of Plaque Psoriasis

Published: May 16, 2022

Product: AVT04, a Proposed Biosimilar to Stelara

  • The (AVT04-GL-101) PK study evaluates PK, safety, tolerability, and immunogenicity of AVT04 (SC, 45mg/0.5mL) vs US-licensed & EU-approved Stelara in 294 healthy adult patients at Australia & New Zealand
  • The results showed bioequivalence of AVT04 to Stelara with no clinical safety differences @28wks. The results from the confirmatory efficacy & safety study for AVT04 are expected before the end of Q2’22
  • On Dec 2021, Alvotech collaborated with Oaktree where the combined company’s securities are expected to be listed on NASDAQ under the symbol “ALVO”. Ustekinumab is a human IgG1k mAb that binds to the p40 protein subunit utilized by interleukin-12 and interleukin-23 cytokines with high specificity

Teva’s Ongavia (biosimilar, ranibizumab) Receives the MHRA’s Approval for the Treatment of Eye Diseases

Published: May 17, 2022

Product: Ongavia (biosimilar, ranibizumab)

  • The MHRA has approved Ongavia, a biosimilar referencing Lucentis for multiple ophthalmic conditions
  • Ongavia is also licensed for the treatment of visual impairment due to DME, PDR, visual impairment due to macular oedema secondary to RVO & visual impairment due to CNV. In the P-III (COLUMBUS-AMD) study, Teva's biosimilar ranibizumab is highly similar to its reference Lucentis in terms of clinical efficacy, ocular & systemic safety for AMD & additional indications
  • Under the agreement with Bioeq AG, Teva will have exclusive commercialization rights for ranibizumab biosimilar in the UK, EU & Canada. The biosimilar is under EC’s review & submission is expected to be completed in late 2022 for Canadian approval

Viatris and Biocon Launched Abevmy (biosimilar, bevacizumab) for the Treatment of Cancer in Canada

Published: May 19, 2022

Product: Abevmy (biosimilar, bevacizumab)

  • The companies launched Abevmy (biosimilar bevacizumab) referencing Avastin for the treatment of multiple types of cancer in Canada. Abevmy is the third oncology biosimilar & has been co-developed by Viatris and Biocon Biologics
  • Abevmy is available to patients in the form of 100mg/4 mL single-use vials and 400mg/4 mL single-use vials. The companies have launched Viatris Advocate program that enables patients to access Abevmy & provides support and resources for patients, caregivers, and healthcare providers
  • Under the Feb 2022 agreement with Viatris, Biocon Biologics will acquire Viatris' biosimilars portfolio globally, including Abevmy for ~$3.3B. The. The transaction is expected to close in H2’22

The EMA Rejects Prestige BioPharma’s Tuznue and Hervelous, a proposed biosimilars of trastuzumab for HER2-Positive Breast and Gastric Cancers

Published: May 20, 2022

Product: Tuznue and Hervelous, a proposed biosimilars of trastuzumab

  • The EMA’s CHMP has issued an opinion recommending the refusal of marketing authorization for Tuznue and Hervelous, a proposed biosimilar of Roche’s Herceptin to treat HER2+ breast & gastric cancer
  • The CHMP stated that the Tuznue manufacturing process used in clinical testing was not the same as the process used in commercial production. The CHMP concluded that the studies did not provide enough evidence to show that the biosimilar candidate would be bioequivalent to the reference trastuzumab
  • The biosimilar was to be marketed as Hervelous in Belgium and Tuznue in the other EU member nations. The company plans to apply for a re-examination of HD201 to the EMA within 15 days of receiving the opinion

Samsung Bioepis & Celltrion Report Results of CT-P13 and SB2 (biosimilar, infliximab) in Prospective Study for the Treatment of Inflammatory Bowel Disease

Published: May 28, 2022

Product: CT-P13 and SB2 (biosimilar, infliximab)

  • The new study showed that multiple switches b/w infliximab biosimilars CT-P13 & SB2 and the reference infliximab were found to be safe & effective for IBD. The study was published in Inflammatory Bowel Diseases
  • Patients with multiple switch group/ CT-P13 to SB2/reference infliximab to CT-P13 group showed clinical remission (76.9%/65.7%/76.9%); treatment persistence (85%/87.0%/70.1%) @12mos.; new ADAs after switch (0%/3.8%/3.7%); discontinued treatment due to active disease & sustained remission (8.7% & 8.7%/8.8% & 1.3%/14.8% & 22.2%); due to AEs (2.9%/3.8%/14.8%)
  • Additionally, no significant differences in the rate of remission @12mos, patients who switched from CT-P13 to SB2 had a lower rate of clinical remission than the other 2 groups

Amneal & Kashiv Receive the US FDA’s Approval for Fylnetra (biosimilar, pegfilgrastim)

Published: May 31, 2022

Product: Fylnetra (biosimilar, pegfilgrastim)

  • The US FDA has approved the BLA for pegfilgrastim, a biosimilar referencing Neulasta for neutropenia. The product has been developed in collaboration with Kashiv & will be available under the name Fylnetra
  • The approval marks Amneal's third biosimilar approval for oncology-related products in 2022 & Kashiv’s second biosimilar approval in the same year. The companies also received approval for Releuko (filgrastim-ayow), a biosimilar referencing Neupogen & Alymsys (bevacizumab-maly), a biosimilar referencing Avastin
  • Pegfilgrastim is expected to be available in H2’22 with a full patient support program. Kashiv plans to continue providing high-quality biosimilars to markets globally over the next few yrs.

Related Post: Insights+ Key Biosimilars Events of April 2022


Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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