Insights+ Key Biosimilars Events of August 2021

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Insights+ Key Biosimilars Events of August 2021

Insights+ Key Biosimilars Events of August 2021

  • 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 August, Samsung Bioepis Byooviz (biosimilar, ranibizumab) received EC's approval for ophthalmic, Celltrion's Herzuma (biosimilar, trastuzumab) overtook the original treatments for cancer. Our team at PharmaShots has summarized 12 key events of the biosimilar space of August 2021

Celltrion to Supply Herzuma (biosimilar, trastuzumab) and Truxima (biosimilar, rituximab) in Brazil

Published: Aug 04, 2021

Product: Herzuma (biosimilar, trastuzumab) and Truxima (biosimilar, rituximab)

  • The company has signed a supply agreement for 2 anticancer biosimilars, Herzuma (trastuzumab) and Truxima (rituximab) in Brazil. The supply of Herzuma accounts for ~80% of Brazil's trastuzumab market
  • Additionally, the company also won orders from eight state governments in Brazil for Truxima, including a bid in Sao Paulo. Following this, the company plans to expand its presence in Latin America
  • In March 2021, the company has initiated direct sales of infliximab biosimilar in Colombia and plans for rituximab and trastuzumab biosimilars in June & July respectively. The company also plans to expand its sales in Peru and Chile in Q3’21

Formycon and Bioeq Report Submission of BLA to the US FDA for FYB201 (biosimilar, ranibizumab)

Published: Aug 05, 2021

Product: FYB201 (biosimilar, ranibizumab)

  • Formycon and partner Bioeq have submitted a BLA for FYB201 (biosimilar referencing Lucentis) to the FDA
  • Lucentis is a mAb fragment used to treat various types of macular-degenerative diseases and other serious eye diseases. If approved, Coherus will commercialize FYB201 in the US
  • Currently, Formycon has four biosimilars while Coherus also has a biosimilar bevacizumab CHS-305 which is currently under development in collaboration with Innovent

Polpharma & Bioeq Report BLA Submission to the US FDA for FYB201 (biosimilar, ranibizumab)

Published: Aug 06, 2021

Product: FYB201 (biosimilar, ranibizumab)

  • Polpharma has reported that its JV company, Bioeq has submitted a BLA for FYB201 (biosimilar referencing Lucentis) to the FDA. FYB201 was originally licensed from Formycon AG
  • The launch of biosimilar ranibizumab may increase market competition, reduce cost and expand patient access with proven analytical & clinical similarity to Lucentis
  • Lucentis is a mAb fragment used to treat various types of macular-degenerative diseases including wet AMD, DR, macular edemas and MCNV. If approved, Coherus will commercialize FYB201 in the US

Celltrion's Herzuma (biosimilar, trastuzumab) Overtook the Original Treatments for Cancer

Published: Aug 11, 2021

Product: Herzuma (biosimilar, trastuzumab)

  • Herzuma wins <51% of the market share in Japan in Jun'21 & secured the top position with the reliability proved by the expanding prescriptions globally. Celltrion is co-promoting Herzuma along with Nippon Kayaku
  • Celltrion also mentioned the Japanese government's policy change as another factor to affects Herzuma prescription positively. Tokyo has added a policy to promote biosimilar drugs in Prime Minister Yoshihide Suga's Honbebuto Paper in Jun'21
  • Celltrion has declared the bids for Herzuma & Truxima in Brazil and Japan. The company plans to launch Remsima (infliximab) & Yuflyma (adalimumab)

CVS Dropped Sanofi's Diabetes Drugs Lantus for Biosimilars

Published: Aug 13, 2021

Product: Biosimilar

  • CVS dropped Sanofi's Lantus drug from the list of medicines & reimburses on behalf of health insurers. The company reported that the number of changes to its formulary & helped private-sector medical insurers to negotiate better prices from drugmakers and also draw up formularies
  • Novartis and Actelion were also dealt blows by CVS's new formulary. Additionally, the patent on Lantus has expired in 2015 in the US, and Sanofi hopes to revive declining diabetes sales with Toujeo which launched in Mar'15
  • Sanofi shares decreased to 1.4% at 1250 GMT, its last week sales were decreased to 3.5 % at constant exchange rates to $1.8B

Centus Reports Results of FKB238 (bevacizumab, biosimilar) in P-III AVANA Trial for the Treatment of Advanced/Recurrent nonsq.NSCLC

Published: Aug 19, 2021

Product: FKB238 (bevacizumab, biosimilar)

  • The P-III AVANA trial compares the efficacy and safety of FKB238 (IV, 15 mg/kg) vs Avastin in a ratio (1:1) in patients with advanced/recurrent non-sq.NSCLC
  • Results: ORR (51.6% vs 53.7%); m-PFS (7.72 vs 7.62 mos.); m-OS (14.13 vs 16.95 mos.), TEAEs was 94.2% and 95.1%, patients experienced grade 3 or higher TEAEs (53.6% and 55.5%) respectively
  • Currently, two bevacizumab biosimilars have been available in the US i.e., Mvasi (Amgen) and Zirabev (Pfizer) which launched in July'19 & Dec'19 respectively. FKB238 is currently under FDA's review while the P-I study demonstrated PK properties & good tolerability without antidrug Ab development

Enzene Receives Marketing Authorization for Romiplostim (biosimilar) in India

Published: Aug 20, 2021

Product: Romiplostim biosimilar

  • DCGI has granted the marketing authorization to Enzene's Romiplostim biosimilar for the treatment of chronic ITP in adults
  • The company provides all the three dosage strengths of the product (125mcg, 250mcg, and 500mcg)
  • Romiplostim is an Fc-peptide fusion protein that increases platelet production through activation of the thrombopoietin receptor. The company's first biosimilar Teriparatide has been launched in early 2021 for the treatment of osteoporosis

Samsung Bioepis Byooviz (biosimilar, ranibizumab) Receives EC's Approval for the Treatment of Ophthalmic in EU

Published: Aug 23, 2021

Product: Byooviz (biosimilar, ranibizumab)

  • The EC has approved Byooviz (biosimilar, ranibizumab) in the EU for the treatment of Ophthalmic disease
  • Lucentis is used to treat ophthalmic disease & macular degeneration. Byooviz marks the 1st biosimilar referencing Lucentis to be commercialized in the EU
  • Samsung Bioepis & Biogen also plans to commercialize an aflibercept biosimilar SB15 which is currently in a P-III trial. Additionally, Samsung Bioepis has a pipeline of 10 products and blockbuster biosimilar products in its portfolio

Sandoz Reports Results of Omnitrope (biosimilar, somatropin) in PATRO Children Study for the Treatment of Turner Syndrome

Published: Aug 23, 2021

Product: Omnitrope (biosimilar, somatropin)

  • The PATRO Children, post-marketing surveillance study evaluates biosimilar rhGH (Omnitrope) vs reference rhGH (Genotropin) in 348 children with TS at 130 centers across the EU. In this study, 81.6% were rhGH naïve, and 90.2% were prepubertal
  • The results demonstrated that the therapy was safe & effective in real-life clinical practice, and was generally well tolerated with no unexpected safety signals.
  • The mean duration of treatment was 38.5mos., 48.9% experienced AEs substantial height gains in prepubertal individuals aged 3+ yrs. Additionally, 49.4% of patients discontinued the study

Nora Signs an Exclusive Agreement Biopharmaceutical Partner to Launch a Biosimilar in Canada

Published: Aug 24, 2021

Product: Biosimilar

  • Nora collaborates with a biopharmaceutical partner to obtain the commercial rights for a biosimilar drug
  • The collaboration will support both private insurers and public formularies by reducing the costs of biosimilars & provide accessibility to patients for high quality affordable pharmaceutical products
  • Nora Pharma's activities coordinate with the biosimilars transition policy adopted by several Canadian provinces

Cipla Collaborates with Kemwell to Form Joint Venture to Develop and Commercialize Biosimilars

Published: Aug 25, 2021

Product: Biosimilar

  • The companies collaborated to form JV to develop, manufacture, and commercialize biosimilars for a global market
  • The collaboration will utilize Cipla and Kemwell's strengths for product development, clinical development, regulatory filings, manufacturing, and commercialization of biopharma products
  • Cipla's respiratory expertise & Kemwell's biologics will combine to accelerate the products in the market

Bio-Thera and Hikma Sign an Exclusive Commercialization and License Agreement for BAT2206 (biosimilar, ustekinumab) in the US

Published: Aug 30, 2021

Product: BAT2206 (biosimilar, ustekinumab)

  • Bio-Thera to receive $20M upfront and $130M as development and commercial milestones and will be responsible for the development, manufacturing, and supply of BAT2206
  • Hikma get exclusive rights to commercialize the biosimilar in the US and received first-right-to-negotiate to add Europe (excluding CIS countries)
  • BAT2206 is a mAb, that is a proposed biosimilar referencing Janssen's Stelara (ustekinumab) and is currently in a global P-III clinical trial

Source: Politico

Related Post: Insights+ Key Biosimilars Events of July 2021


Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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