• 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 Jul, Viatris & Biocon's Semglee got the US FDA's approval as the first interchangeable biosimilar for diabetes whereas Mabpharm's Biobetter (CMAB008) for infliximab received NMPA's approval. Our team at PharmaShots has summarized 12 key events of the biosimilar space of July 2021

STADA and Xbrane's Xlucane (biosimilar, ranibizumab) Meet its Primary Endpoint in P-III Xplore Study

Published: Jul 01, 2021

Product:  Xlucane (biosimilar, ranibizumab)

• The P-III Xplore study involves assessing ranibizumab biosimilar vs Lucentis in 583 patients. The study met its 1EPs demonstrating the equivalent efficacy in BCVA @ 8wks. treatment
• Additionally, the interim analysis of 6mos. data demonstrated that the biosimilar has a similar PK, safety, and immunogenicity profile compared to Lucentis. The companies plan to submit MAA to EMA and BLA to FDA in H2'21
• In July'18, the companies have entered a co-development agreement for a biosimilar of Lucentis and share equal development expenses and profits from commercialization. The companies are currently evaluating commercialization options for other countries globally

Gan Lee Presents P-I Results of Proposed Biosimilar Insulins Aspart, Lispro and Glargine at ADA 2021

Published: Jul 05, 2021

Product:  Proposed Biosimilar Insulins Aspart, Lispro, and Glargine

• The company reported that all the P-I studies assessing insulin aspart (GL-ASP), insulin lispro (GL-LIS), and insulin glargine (GL-GLA) met their primary PK & PD analyses and demonstrated that PK/PD bioequivalence b/w each of the proposed biosimilar and their respective reference compounds
• The safety profiles were comparable b/w each of the three proposed biosimilar and their respective reference compounds
• The company is working to bring biosimilar insulins into clinical practice with the goal of reducing the global burden of diabetes

Alvotech Initiates AVT04-GL-301 Study of AVT04 Proposed Biosimilar to Stelara (ustekinumab) for the Treatment of Plaque Psoriasis

Published: Jul 07, 2021

Product:  AVT04 Proposed Biosimilar to Stelara

• The first patient has been dosed in the comparative, confirmatory efficacy, and safety AVT04-GL-301 clinical study to evaluate AVT04 vs Stelara in ~ 530 patients with plaque psoriasis across five countries in the EU
• The purpose of the study is to demonstrate therapeutic equivalence b/w AVT04 and Stelara in terms of safety, efficacy, and immunogenicity
• Additionally, the company is also conducting an AVT04-GL-101, PK similarity study to assess equivalent PK endpoints, safety and tolerability for AVT04 in ~ 294 healthy adult volunteers across Australia and New Zealand

Teva Enters into a Commercialization Agreement with Bioeq for FYB201 (biosimilar, ranibizumab)

Published: Jul 08, 2021

Product: FYB201 (biosimilar, ranibizumab)

• Polpharma Biologics has reported that its JV company, Bioeq collaborates with Teva to commercialize Bioeq's FYB201 (biosimilar referencing Lucentis) in the EU, Canada, Israel & New Zealand
• The launch of biosimilar ranibizumab may increase market competition, reduce cost and expand patient access with proven analytical & clinical similarity to Lucentis while FYB201 was originally licensed from Formycon AG
• The recent agreement with Teva complements a previous agreement with Coherus BioScience for commercialization in the US. Lucentis is a mAb fragment that has been approved to treat wet AMD

Menagen Signs a Commercialization Agreement with CKD for Biosimilar Darbepotein Alfa

Published: Jul 13, 2021

Product:  Biosimilar Darbepotein Alfa

• The companies collaborated to commercialize the first biosimilar Darbepoetin alpha in the GCC market for the treatment of anemia associated with chronic renal failure. The CKD biosimilar is currently approved in South Korea
• The collaboration with CKD helps to build the biosimilar footprint in the Middle East and Africa markets to reach more people living with severe chronic diseases
• Menagen focuses to provide broad access to patients with unmet medical needs by utilizing its local expertise and capabilities and focus on various niche therapeutic products

Bio-Thera Reports First Patient Dosing in P-III Study for BAT2206 Proposed Biosimilar of Stelara (ustekinumab)

Published: Jul 16, 2021

Product:  BAT2206 Proposed Biosimilar

• The first patient has been dosed in a P-III clinical study evaluating the efficacy and safety of BAT2206 vs reference Stelara in ~ 472 patients with moderately to severely PsO
• BAT2206 represents the 4th biosimilar of Bio-Thera's portfolio to enter P-III study. The advancement of BAT2206 in P-III study demonstrates company's commitment to develop biosimilars to expand patient access at lower costs
• Bio-Thera Solutions is developing additional proposed biosimilars, including a bevacizumab biosimilar and a tocilizumab biosimilar that have completed global P- III clinical trials. The company is also pursuing biosimilar versions of golimumab, mepolizumab, and dupilumab

Henlius Reports First Patient Dosing in P-I Study of HLX04-O (biosimilar, bevacizumab) for Wet Age-Related Macular Degeneration

Published: Jul 19, 2021

Product:  HLX04-O (biosimilar, bevacizumab)

• The first patient has been dosed in a P-I study of HLX04-O conducting in patients with wAMD. The primary objective of the study is to evaluate the safety & tolerability of HLX04-O in 6-12 patients with wAMD
• The secondary objective of the study is to evaluate the PK profiles of HLX04-O after intravitreal injection
• In Oct'2020, Henlius signed co-development and exclusive license agreement with Essex. The companies plan to conduct clinical trials of HLX04-O in China, Australia, EU, and the US, and apply marketing authorization in different countries and regions across the globe

Samsung Bioepis Initiates P-III Clinical Trial of SB17 Proposed Biosimilar to Stelara (ustekinumab)

Published: Jul 20, 2021

Product:  SB17 Proposed Biosimilar to Stelara

• The company initiates P-III clinical trial to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 vs Stelara in a ratio (1:1) in patients with moderate to severe plaque psoriasis
• Additionally, patients either continue on Stelara or transition to SB17 @28wks. The IPs (SB17 or Stelara, q12w) will be administered @0, 4 and for up to 40wks. and the last assessment will be performed @52wks.
• The company continues to advance a broad pipeline of biosimilar candidates covering therapeutic areas, including immunology, oncology, ophthalmology, hematology, endocrinology, and gastroenterology

Mabpharm's Biobetter (CMAB008) for Infliximab Receives NMPA's Approval in China

Published: Jul 22, 2021

Product:  Biobetter (CMAB008)

• NMPA has granted approval to market infliximab biobetter in China. Sorrento holds exclusive commercial rights to Infliximab biobetter Ab outside of China and plans to file a BLA for the product in the US and EU in 2021
• Biobetters are drugs that have similar structure and properties to an innovator product but are enhanced to produce better outcomes. The biobetter Ab produced in CHO cells has demonstrated a better safety profile than the parent mouse cell produced product, while maintaining its efficacy profile
• The approval covers 6 autoimmune and inflammation indications. Sorrento plans to meet with regulatory agencies to determine the best path towards registration for the US and EU

Meiji and Dong-A ST Sign an Exclusive License Agreement with Intas to Commercialize DMB-3115, Proposed Biosimilar to Ustekinumab

Published: Jul 23, 2021

Product:  DMB-3115, Proposed Biosimilar to Ustekinumab

• Meiji and Dong-A ST to receive an upfront & will be eligible to receive development & sales milestones along with profit share. The companies collaborated to commercialize DMB-3115 proposed biosimilar to ustekinumab for the treatment of inflammatory diseases such as PsO, CD & UC
• Intas to get exclusive license rights to commercialize DMB-3115 globally, Ex-Japan, Korea & Asia. Meiji and Dong-A ST will develop and manufacture DMB-3115 and supply the product to Intas and its WW affiliates
• DMB-3115 is being evaluated in a P-III multi-regional clinical trial to treat patients with PsO in the EU & US

Abzena and BioXpress Collaborate to Develop and Manufacture Biosimilars for Third-Party Customers

Published: Jul 23, 2021

Product:  DMB-3115, Proposed Biosimilar to Ustekinumab

• The alliance creates an integrated solution between the companies with expertise in biosimilar development and GMP manufacture
• The collaboration will benefit biosimilar drug developers with the design consultancy, cell line and process development through to clinical and commercial GMP manufacture
• The partnership provides a flexible & innovative approach from small scale biosimilar development through to large scale manufacturing

Viatris and Biocon's Semglee (biosimilar, insulin glargine) Receive the US FDA's Approval as the First Interchangeable Biosimilar for Diabetes

Published: Jul 29, 2021

Product:  Semglee (biosimilar, insulin glargine)

• The US FDA has approved Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the 351(k) regulatory pathways to treat diabetes
• Semglee will allow pharmacy level substitution for the reference product, Lantus across the US & will be launch before the end of 2021. Biocon is eligible to have exclusivity for 12mos. from the date of commercial launch of the biosimilar
• Semglee has an identical amino acid sequence to Lantus and has received regulatory approval in 60+ countries globally. The biosimilar marks the third US FDA approved product under Viatris-Biocon collaboration

Source: Drug Target Review

Related Post: Insights+ Key Biosimilars Events of June 2021