Insights+ Key Biosimilars Events of December 2022

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Insights+ Key Biosimilars Events of December 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 December, Alvotech and STADA launched Hukyndra (biosimilar, adalimumab) in EU, Fresenius Kabi’s Idacio (biosimilar, adalimumab) received the US FDA’s approval for the treatment of chronic autoimmune diseases. Our team at PharmaShots has summarized 10 key events of the biosimilar space of December 2022

1. Capstone’s Biosimilar Human Insulin Receives Marketing Authorization in Canada and EU

Date- December 01, 2022   

Product: N/A

  • The EMA’s CHMP granted approval for a biosimilar version of human insulin in the EU & the same biosimilar received a Notice of Compliance (NoC) from Health Canada
  • The biosimilar (ready-to-use insulin) was developed by Capstone’s affiliate company Celerity in collaboration with a leading medical products company and is formulated as an IV inf. in a flexible plastic container in 0.9% sodium chloride inj. If approved, the biosimilar can be administered to patients in hospitals and other acute settings
  • The product lowers blood sugar by facilitating glucose uptake into muscle and fat cells while also preventing the liver from excreting glucose. The product was approved in the US in 2019

2. Accreditation Council for Medical Affairs Begins Board Certification Program for Biologics and Biosimilars

Date- December 06, 2022   

Product: N/A

  • The ACMA is launching a board-certified biologic and biosimilars specialist program (BCBBS), the first accredited program specializing in biologics & biosimilars
  • The BCBBS program is a self-paced & the first and only US and international board certification program for health care professionals & researchers. The focus is to establish expertise among professionals involved in the optimization of biological therapy
  • The certification covers a variety of topics incl. the history of biologics, FDA resources, the Purple Book, regulatory & economic considerations, clinical guidelines, real-world evidence, and the future outlook on biosimilars. The program consists of 8 modules completed over 6mos. for an avg. of 40hrs.

3. Alvotech and STADA Launch Hukyndra (biosimilar, adalimumab) in the EU

Date- December 07, 2022   

Product: Hukyndra (biosimilar, adalimumab)

  • Alvotech & STADA launched adalimumab biosimilar referencing Humira in 7 countries across the EU: Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania & Slovenia, following the initial launch in June 2022 in 9 other EU countries
  • STADA gets Hukyndra autoinjectors & pre-filled syringes with drug products & drug substances manufactured in an EU facility in Reykjavik, Iceland & holds the marketing authorization rights in the EU, US & multiple other countries, supports adalimumab launches in national markets through tailored educational materials & patient-support programs
  • Hukyndra was approved in the EU, Norway, Iceland, Lichtenstein, the UK & Switzerland; Canada as Simlandi & Australia as Ciptunec/ Ardalicip, now under review in multiple countries, incl. in the US

4. Biogen Reports the US FDA’s Acceptance of Abbreviated BLA of BIIB800 (biosimilar, tocilizumab) for Rheumatoid Arthritis

Date- December 09, 2022   

Product: BIIB800 (biosimilar, tocilizumab)

  • The US FDA has accepted aBLA for review of BIIB800, an ACTEMRA biosimilar. If approved, BIIB800 will be used for the treatment of incl. RA, idiopathic polyarthritis, idiopathic arthritis & sclerosis-associated ILD
  • The filing was based on the P-III trial assessing BIIB800 vs ACTEMRA in 621 patients with RA with an inadequate response to methotrexate. The results showed an equivalent efficacy & comparable safety and immunogenicity profile to the reference tocilizumab
  • Under the April 2021 agreement with Bio-Thera Solutions, Biogen gains exclusive worldwide regulatory, manufacturing & commercial rights of BIIB800 except China (incl. Hong Kong, Macau & Taiwan)

5. Sunshine Lake Pharma Reports P-I Study Results of Liraglutide Biosimilar RD12014 for Type 2 Diabetes

Date- December 10, 2022   

Product: RD12014

  • The company reported the P-I trial results evaluating liraglutide biosimilar RD12014 vs Victoza in a ratio (1:1) in 50 healthy male patients with T2D
  • The results showed that the PK, safety and immunogenicity were similar b/w the liraglutide biosimilar RD12014 and the reference Victoza, TRAEs were reported in (22.4% vs 24.5%). The results were used to support an NDA in China
  • The reference Victoza is currently used as an SC inj. for T2D & has been approved as an adjunct therapy to diet and exercise in the EU & the US along with approval in the US & China to prevent cardiovascular events in adults with T2D

6. Fresenius Kabi’s Idacio (biosimilar, adalimumab) Receives the US FDA’s Approval for the Treatment of Chronic Autoimmune Diseases

Date- December 14, 2022   

Product: Idacio (biosimilar, adalimumab)

  • The US FDA has approved citrate-free adalimumab biosimilar, Idacio for chronic autoimmune diseases. The product is expected to be available in the US in July 2023 as a self-administered prefilled syringe and pre-filled pen (autoinjector)
  • The approval was based on a review of a comprehensive data package & totality of evidence that demonstrated a similar analytical profile, PK, efficacy, safety, and immunogenicity over the adalimumab product
  • Idacio is a tumor necrosis factor (TNF) blocker and a biosimilar to Humira. The product has been approved and commercialized in ~37 countries globally & has been developed by Fresenius Kabi SwissBioSim by using advanced analytical methods for multiple chronic conditions

7. Prime Therapeutics will Include Biosimilars to the NetResults Formulary in Addition to Humira

Date- December 16, 2022   

Product: Humira

  • Prime Therapeutics will include biosimilars alongside AbbVie’s rheumatoid arthritis drug Humira on its preferred list of drugs, the NetResults formulary. The decision is expected early in 2023 incl. 8 biosimilars referencing Humira are expected to be launched with Amgen’s Amjevita
  • Humira is used for the treatment of RA, CD, and other diseases. The use of biosimilars will deliver the lowest net cost options & helps ensure optimal, cost-effective therapy for complex inflammatory conditions
  • Fresenius Kabi’s adalimumab biosimilar Idacio referencing Humira was approved in Dec 2022 & expected to be launched after July 2023

8. Dr. Reddy Reports the Completion of P-I Study for DRL_TC, a Proposed Biosimilar of Tocilizumab to Treat Active Rheumatoid Arthritis

Date- December 19, 2022   

Product: Tocilizumab

  • The company reported the results from the P-I study evaluating DRL_TC vs EU & US reference products in patients with mod. to sev. active RA who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs. The proposed tocilizumab biosimilar is being developed as both SC & IV formulations
  • The trial met its 1EPs & 2EPs which showed PK equivalence and similarity in PD parameters, safety, and immunogenicity b/w Dr. Reddy’s proposed biosimilar candidate DRL_TC and EU reference & US reference product
  • The company also initiated the P-III study to compare the efficacy, safety, tolerability, and immunogenicity of DRL_TC vs reference product for the same indication

9. Sandoz Canada Supports Ontario’s Biosimilars Switching Policy

Date- December 22, 2022   

Product: N/A

  • The Ontario government has approved the use of more biosimilar drug treatments & establish a biosimilar switching policy to improve patient access to quality medicines. The transition will begin Mar 2023 & completed at the end of 2023
  • Ontario drug benefit recipients who are on an originator biologic (prescription drug) will begin to transition to a Health Canada-approved biosimilar version of the drug & the program will initially focus on reference biologics for chronic conditions i.e., arthritis, diabetes, inflammatory bowel disease & psoriasis
  • Sandoz Canada supports patients, healthcare professionals & Ontario Government with quality biosimilar medicines and patient support programs & currently has 6 biosimilars in Canada (Omitrope, Erelzi, Riximyo, Hyrimoz, Ziextenzo & Inclunox)

10. Biocon Reports P-I Study (RHINE-3) Results of Biosimilar Insulin

Date- December 25, 2022   

Product: Insulin-70/30 and Humulin-70/30

  • The P-I study (RHINE-3) evaluating a single dose of 0.4IU/kg of Biocon's Insulin-70/30 vs US-licensed Humulin-70/30 vs in a ratio (1:1) in 78 patients
  • The results showed a PK & PD equivalence b/w the biosimilar insulin-70/30 and Humulin-70/30 as a single SC administration for the primary EPs. The study also showed equivalence for the secondary PK/PD EPs & was well-tolerated with no clinically relevant differences in the safety profiles & no serious AEs were reported
  • Additionally, plasma insulin concentrations and glucose infusion rates (GIRs) were assessed over 24hrs., no serious AEs, deaths, or discontinuations due to safety or tolerability reasons were reported

Related Post: Insights+ Key Biosimilars Events of November 2022


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 [email protected].

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