Pearce IP BioBlast w/e 26 April 2024

The Korean Biomedical Review has reported that Samil Pharmaceutical will launch Samsung Bioepis’ aflibercept in Korean market from 1 May 2024.  Samil and Samsung Bioepis entered into a B2B commercialisation deal for biosimilar aflibercept in February 2024, following their agreement for biosimilar ranibizumab in June 2022.

On 26 April 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes of the applications for reimbursement considered at its March 2024 meeting.

The following biosimilars have been recommended for listing on the Pharmaceutical Benefits Scheme (PBS):

• Amgen’s Wezlana® (ustekinumab); and
• Celltrion’s Yuflyma® (adalimumab) and Vegzelma® (bevacizumab).

In addition, the following biopharmaceuticals have been recommended for first time listing on the PBS:

• AstraZeneca’s Enhertu® (trastuzumab deruxtecan) for the treatment of patients with HER2-low unresectable or metastatic breast cancer, and Saphnelo® (anifrolumab) for the treatment of patients with severe systemic lupus erythematosus with high disease activity despite standard of care;
• UCB’s Bimzelx® (bimekizumab) for the treatment of severe psoriatic arthritis;
• new forms of Janssen-Cilag’s Stelara® (ustekinumab), as 45 mg and 90 mg pre-filled syringe (PFS) and pre-filled pen (PFP); and
• a new subcutaneous form and strength of Roche’s Tecentriq® (atezolizumab).

PBAC reports that applications for an Authority Script PBS listing of Regeneron’s Eylea® (aflibercept) for the treatment of patients with visual impairment due to DMO and for the treatment of visual impairment caused by CNV secondary to AMD are to be considered at a “future” PBAC meeting.

On 25 April 2024, Biogen announced that its Tofidence™ (tocilizumab), biosimilar to Roche’s RoActemra®, received a positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP).  The recommendation relates to the IV formulation of tocilizumab for the treatment of moderate to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.  The Biogen application was accepted by EMA 19 months earlier in September 2022.

The product, previously known as BAT1806, was developed by Bio-Thera, and Biogen acquired exclusive rights in all countries other than China in a deal announced in April 2021.

This follows the FDA approval of Biogen’s Tofidence™ on 30 September 2023, and the US patent settlement between Roche, Genentech, Chugai and Biogen in October 2023.

On 25 April 2024, EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for Amgen’s Wezenla™ (ustekinumab), biosimilar to Janssen’s Stelara®.   Wezenla™ is proposed to be available in a 45 mg and 90 mg solution for injection, as well as a 130 mg solution for infusion.

Amgen’s Wezlana™ was approved in the US in October 2023, was launched in Canada in March 2024 and was listed on the Australian PBS in January 2024.

CHMP’s positive recommendation for Wezenla™ comes days after Samsung Bioepis’ Pyzchiva® (ustekinumab) was approved in the EU on 25 April 2024.

On 25 April 2024, Evernorth, a provider of health services and member of the Cigna Group, announced that it will offer biosimilar adalimumab to US patients with no patient out-of-pocket costs from June 2024, resulting in savings to the patient of around US $3,500 per year . This biosimilar will be accessible to eligible patients through its specialty pharmacy, Accredo.

The first Humira® biosimilar [Amgen’s Amjevita], was launched in the US on 31 January 2023, with multiple additional biosimilars entering the US market in July 2023.

On 24 April 2024, the FDA released an updated draft guidance document  on the marketing of prescription biological reference products, biosimilar products, and interchangeable biosimilar products  seeking input from industry by 25 June 2024.

The revised guidance largely maintains the content from the 2020 version but seeks to “addresses questions firms may have when developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products licensed under section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)) and prescription biosimilar products, including interchangeable biosimilar products, licensed under section 351(k) of the PHS Act (42 U.S.C. 262(k))”.

Comments on the draft guidance can be submitted here until 25 June 2024.

On 24 April 2024, Alvotech announced positive topline results from a confirmatory clinical study of AVT05 (golimumab), with the biosimilar demonstrating therapeutic equivalence to Janssen’s Simponi® and Simponi Aria® in patients with moderate to severe rheumatoid arthritis.

Alvotech is the first company to publicly announce positive topline results from a patient study evaluating a biosimilar candidate to Simponi® or Simponi Aria®.

These results follow Alvotech’s announcement in November 2023 that its pharmacokinetic study for AVT05 met its primary endpoint.

On 24 April 2024, IAM reported that information on the first biosimilar disputes in the Unified Patents Court (UPC)has become publicly available.

The first of these disputes were filed by Alexion on 19 March 2024 at the Hamburg Local Division of the UPC against each of Samsung Bioepis (Case No. ACT_13849/2024) and Amgen (Case No. ACT_13886/2024).  Alexion is seeking provisional measures in relation to EP 3 167 888, which concerns a method of treating paroxysmal nocturnal hemoglobinuria using eculizumab, marketed by Alexion as Soliris®.

Samsung Bioepis obtained EC marketing authorisation for Epysqli® (eculizumab) on 30 May 2023 and launched it in 3 European countries in October 2023.  Amgen obtained EMA approval for Bekemv® (eculizumab) on 19 April 2023.

Alexion is also suing Samsung Bioepis in the US, asserting infringement of six US eculizumab patents and has been in dispute with Amgen in Germany, with the Munich Higher Regional Court overturning Alexion’s preliminary injunction order regarding Amgen’s off label-use of Bekemv® in February 2024.

The second set of UPC biosimilar disputes was commenced on 9 April 2024 in the Dusseldorf Local Division by Novartis and Genentech (case Numbers: ACT_18492/2024 and ACT_18551/2024) seeking provisional measures against Celltrion.  The actions relate to EP 3 805 248, regarding pharmaceutical formulations of omalizumab, marketed by Novartis and Genentech as Xolair®.  The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for Celltrion’s omalizumab biosimilar, Omlyclo®, on 22 March 2024.

On 22 April 2024, Samsung Bioepis announced that the European Commission granted marketing authorisation for its Pyzchiva®, biosimilar to Janssen’s Stelara® (ustekinumab).  The approval comes two months after the CHMP adopted a positive opinion for Pyzchiva® for the treatment of plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease.

Pyzchiva® is one of the first ustekinumab biosimilars approved in Europe, following the approval of Alvotech’s and Stada’s Uzpruvo® in January 2024.  Three days after Pyzchiva® was approved, on 25 April 2024, the CMP issued a positive recommendation for the marketing authorisation of Amgen’s ustekinumab biosimilar, Wezenla™. Pyzchiva® will be commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.

Earlier this month, Samsung Bioepis received Korean approval for Epyztek^TM, the first ustekinumab biosimilar approved in Korea.  Samsung Bioepis has applied to revoke at least two of Janssen’s Stelara® (ustekinumab) Australian patents in the Australian Federal Court. The trial is provisionally scheduled for November 2024.