Significant biosimilar activities this week include:
27 Jul 22 | AU | Viatris (Mylan) seeks PBS listing for etanercept biosimilar
Alphapharm (Viatris’ Australian subsidiary) has its etanercept biosimilar, Nepexto®, on the agenda for the November PBAC meeting. If the PBAC recommends that Nepexto is PBS-listed, it will become the third PBS-listed etanercept product after Pfizer’s Enbrel® and Arrow’s Brenzys®.
29 Jul 22 | US | Celltrion submits IND application to FDA regarding Yuflyma® interchangeability studies
Celltrion Healthcare has reportedly filed an IND application to the FDA for a phase III clinical trial to demonstrate the interchangeability of its Yuflyma® (adalimumab) biosimilar and AbbVie’s Humira®. The trial will involve 366 patients with plaque psoriasis. Following Celltrion’s aBLA filing in late 2020 and its settlement with AbbVie in Q1 of 2021, Celltrion plans to launch in the US on 1 July 2023.
29 July 2022 | AU | Samsung commences third revocation suit against newly granted Fresenius 50mg/ml adalimumab formulation patent
A third revocation proceeding was commenced by Samsung Bioepis against a Fresenius Kabi adalimumab 50 mg/mL formulation patent AU2020204269 (‘269). The ‘269 patent covers a specific formulation of adalimumab with a specific buffer, sugar, surfactant and pH. These proceedings were commenced a day after the patent was granted (28 July 2022), following Samsung withdrawing its pre-grant opposition on 27 July (which it filed in December 2020).
Samsung commenced a revocation proceeding in June 2022 against a second, related 50 mg/mL adalimumab formulation patent. In 2019, Samsung also sought revocation of a first Fresenius adalimumab formulation patent, which resulted in Fresenius surrendering the patent in November 2019, the proceedings being dismissed by consent, and a costs order against Fresenius being made against Fresenius.
1 Aug 22 | US | AbbVie’s adalimumab patent thicket not anti-competitive
The Court of Appeals for the Seventh Circuit has agreed with the District Court, finding that AbbVie holding 132 US patents relating to Humira®, and settling litigation regarding the same, was not anti-competitive. The decision rejected the appeal filed by welfare benefit payors. The Court commented that there is no cap on the number of patents any one person can hold pertaining to a single subject, that every patent is presumed to be valid, that the appellants have not proved that AbbVie was using invalid patents to protect its monopoly, and that the settlements did not amount to cartel conduct.
1 Aug 22 | US | FDA approves use of ustekinumab in children with psoriatic arthritis
Janssen announced that the FDA has approved Stelara® (ustekinumab) for the treatment of paediatric patients aged six and over with active psoriatic arthritis (PsA). As there were insufficient paediatric patients with PsA to conduct clinical trials, the FDA based its approval on phase III trials in adults and children with plaque psoriasis and adults with PsA.
1 Aug 22 | US | FDA to review Fresenius Kabi’s aBLA for biosimilar tocilizumab
Fresenius Kabi announced that the FDA has accepted for review Fresenius’ biosimilar candidate MSB11456 to Chugai’s Actemra® (tocilizumab). Actemra is presently the only tocilizumab product on the market in the US.
2 Aug 22 | US | FDA approves Coherus’ ranibizumab biosimilar with interchangeability exclusivity
Coherus Biosciences announced that the FDA has approved Coherus’ Cimerli™, a biosimilar to Genentech’s Lucentis® (ranibizumab). Cimerli is the third approved US biosimilar, but is the first to be approved for all five of Lucentis’ indications and to receive the interchangeable designation, resulting in twelve months interchangeability exclusivity.
3 Aug 22 | US | Regeneron sues Viatris (Mylan) for infringement of aflibercept patents
Regeneron has filed a complaint against Mylan in West Virginia under the BPCIA alleging infringement of twenty-four patents relating to Eylea® (aflibercept). This follows the FDA’s acceptance for review of Mylan’s aBLA for its aflibercept biosimilar. Regeneron recently listed twenty-nine patents in the Purple Book as part of its patent dance with Mylan. Mylan previously sought IPR of several aflibercept patents.
4 Aug 22 | Coherus developing high concentration adalimumab formulation
In its earnings call on 4 August 2022, Coherus announced that it is developing a high concentration adalimumab formulation, which it intends to market following launch of its 50mg/ml citrate-free Yusimry™ formulation in July 2023. Coherus also shared its plans to capture “at least 10%” of the Humira® market in its first year of sales, which is capped by its current manufacturing capacity, although Coherus says it “has the potential to triple that capacity”.
4 Aug 22 | Amgen to buy ChemoCentryx for nearly $4 billion
Amgen announced that it has agreed to acquire ChemoCentryx, a biopharmaceutical company focused on auto-immune diseases, inflammatory disorders and cancer, for around $3.7 billion. ChemoCentryx markets Tavneos® (avacopan), a first-in-class treatment for multi-system autoimmune diseases involving small vessel inflammation.
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