Biosimilar Bytes

Last week, Viatris (formerly Mylan) announced during its earnings call that it anticipated that the Food and Drug Administration will provide interchangeability designations to its insulin glargine and insulin aspart candidates when these are approved in July. That could yield a double first—the first biosimilar insulins and interchangeable biosimilars of any type.

As reported in a previous post, based on information from IPD Analytics presented at the annual meeting of the Academy of Managed Care Pharmacy, Alvotech may be one of two companies seeking to launch its high-concentration form of adalimumab biosimilar after approval in 2022. This would be ahead of Amgen’s Amjevita®, which is the first of the scheduled launches in 2023. This may be a reason why: Alvotech USA sought declaratory judgement against AbbVie on May 12th, which would negate AbbVie’s suit claiming that 62 Humira® patents are infringed by Alvotech hf, based in Iceland. As explained by Big Molecule Watch, this was a technical error by AbbVie, which did not name Alvotech USA, a wholly owned subsidiary located in Arlington, Virginia, as a defendant. The complaint filed by Alvotech also claims that AbbVie is engaging “the litigation process itself” to create enormous expenses, risk, and uncertainty, to “deter others from competition” and to challenge their patents.

The US Supreme Court decided that it would not review the Federal Circuit’s July 2020 ruling that prevents Sandoz from launching its etanercept biosimilar Erelzi® until 2029. This seems to be the last gasp for a reasonable US launch timeframe for this etanercept biosimilar, enabling Amgen to retain marketing exclusivity on Enbrel® for an unprecedented 30 years. The federal government could still avoid this fate, if it exercised its Section 1498 option.

If 2029 represents the earliest viable launch date, this seriously puts into doubt whether any biosimilar manufacturer will still be interested. Enbrel’s revenues are falling each year, and other biologic molecules are eating into its marketshare. Other less-expensive biosimilars in the autoimmune space, not the least of which is adalimumab, could further drive potential revenues of etanercept in the near future.

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