Biosimilar Business Roundup: November 2018

During November 2018, biosimilar developers worldwide made tough choices about how to move forward with their products and pipelines.

Early in the month, Sandoz announced that it will no longer pursue FDA approval for its biosimilar rituximab, GP2013, saying that by the time it could reach the market with its drug, the US market’s need would already be satisfied by competitors’ products.

Similarly, Boehringer Ingelheim revealed that it will not seek to launch its EU- and US-approved adalimumab biosimilar, Cyltezo, in Europe. Instead, the biosimilar developer told The Center for Biosimilars^®, it will focus on resolving US patent litigation in an effort to launch the drug prior to 2023, when competitor adalimumab biosimilars are expected to become commercially available.

Among those competitors is Momenta’s M923, which, while not yet approved, is the subject of a recent patent settlement that could allow the drug to reach US patients in November of 2023. News of the settlement came shortly after Momenta told investors that, after a review of its operations, the company has decided focus on its pipeline of novel therapeutics, and will only proceed with 2 late-stage biosimilars, M923 and M710, an aflibercept molecule.

Competition over adalimumab heated up in the European context, where the first biosimilars launched in October. Danish authorities told The Center for Biosimilars^® that it has entered into agreements with 5 companies for 2 tenders for adalimumab products, and that AbbVie’s Humira did not offer the lowest price in either bid. Meanwhile, the United Kingdom has announced that, as a result of its tender for the best-value adalimumab, its National Health Service will save £300 million (approximately $386 million) of its current £400 million-per-year (approximately $514 million) spending on adalimumab.

The United Kingdom also saw the launch of an insulin glargine biosimilar, Mylan and Biocon’s Semglee, this month, which could prove to be a boon for a nation with a high burden of diabetes; the NHS currently spends approximately 10% of its budget on diabetes care.

Finally, UK pharma announced that it has agreed to a 2% cap on annual spending on brand-name drugs in exchange for faster product reviews by the National Institute for Clinical Excellence and the potential for swifter product launches.

November also saw renewed debate over how best to create a thriving market for biosimilars in the United States. Novartis signaled its support of Pfizer’s recent citizen petition to the FDA over biosimilar communications, citing communications that it says do not provide balanced information about biosimilars, and asking regulators to take action against misinformation. Meanwhile, Amgen, one of the developers pointed out by Pfizer in its petition for ostensibly spreading misinformation, confirmed to The Center for Biosimilars^® that it had withdrawn its membership from the trade group the Biosimilars Forum, an organization that also includes both Pfizer and Novartis’ Sandoz.

One area in which developers seemed united was in embracing deeper discounts for their products than the US market has become accustomed to. Coherus Biosciences revealed that it will match the price of Mylan’s biosimilar pegfilgrastim, Fulphila, at a 33% discount to the reference Neulasta when it launches its biosimilar pegfilgrastim, Udenyca, in January of 2019. Pfizer, in launching its epoetin alfa biosimilar, Retacrit, similarly revealed that it had discounted its product by 33.5% versus the reference Epogen.

While reference product sponsors have begun to face added pressure from biosimilar developers, Genentech is also facing a different kind of problem from would-be rivals: 3 former Genentech employees have been charged with conspiring to seal the company’s trade secrets in order to funnel them to biosimilar developer JHL Biotech. Genentech is asking the court to block JHL from developing biosimilars that use its trade secret information.

Finally, Samsung BioLogics, parent company of biosimilar developer Samsung Bioepis, also faced legal trouble of its own making; after the Korean Securities and Futures Commission found that the company had committed fraud, the commission both levied a fine and revealed that Samsung BioLogics could be delisted from the nation’s stock exchange.