Biosimilar Business Roundup: August 2019

In the oncology realm, August 2019’s biggest business development was the forward momentum of Amgen’s 2 newly debuted oncology biosimilars.

First, provider partnership OneOncology announced that its practices have begun to treat patients with Amgen’s anticancer biosimilars, Kanjinti and Mvasi. The biosimilar trastuzumab and bevacizumab agents, respectively, became available in July, and OneOncology said that, as an early adopter, it is beginning to incorporate biosimilars as a way to help deliver quality, cost-effective care.

Additionally, UnitedHealthcare announced that, starting on October 1, the 2 anticancer biosimilar products will be preferred oncology agents for its commercial and community plans. Other biosimilars (which have yet to launch in the US market) will not be preferred.

The drug maker also got a boost from the fact that the federal circuit denied motions from Genentech to block sales of Kanjinti and of Mvasi in 2 separate patent disputes related to the biosimilars.

That was all good news for Amgen, which announced that its biosimilars business generated $82 million in sales in the second quarter of this year. The drug maker did have a least one setback in August, however, when it agreed, in a joint status report to a district court, that it cannot maintain a claim of infringement against rival developer, Mylan, concerning a patent that covers purifying proteins. Amgen had previously claimed that Mylan’s pegfilgrastim biosimilar, Fulphila, infringed on the patent.

Perhaps the biggest news in the biosimilar space from the inflammatory disease perspective also involved Amgen and a patent case: This month saw the outcome of a long-running dispute between Amgen and Sandoz over etanercept. Sandoz did not contest infringement of 2 patents in the case brought by Amgen, Immunex, and Roche, but it said that the patents should be found invalid. The court sided with Amgen, and while Sandoz has said that it will appeal the decision, the outcome could mean that biosimilar etanercept may not reach the US market until the second of the 2 patents expires in 2029.

This month also saw other biosimilar disappointments: Momenta announced that has dropped its biosimilar adalimumab from its pipeline to free up funds for novel drug programs. That move came after a 2018 announcement from the company that it would cease work on the majority of its biosimilar projects.

Looking ahead to future biosimilar programs, Bio-Thera announced that it is entering a phase 1 study of its proposed golimumab biosimilar, referencing Simponi. The reference drug, developed by Janssen, is approved to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis, and it is available in intravenously and subcutaneously administered forms.

Meanwhile, it looks less certain that drug makers are keen to pursue biosimilars of Botox; in a filing with the US Securities and Exchange Commission this month, Silicon Valley—based biotech company Revance Therapeutics said that it has extended the period of time that partner Mylan has to decide whether to continue to develop and commercialize a biosimilar of Allergan’s onabotulinumtoxinA. While the partnership has held at least 1 meeting with the FDA on pursuing a biosimilar, other agents that compete in this space, such as Jeuveau, have been approved as novel agents.

In the rare disease arena, Samsung Bioepis began recruitment for a phase 3 trial of its proposed eculizumab biosimilar, SB12, in patients with paroxysmal nocturnal hemoglobinuria. Meanwhile, the reference eculizumab, Soliris, gained a new indication in the European Union: The product is now approved to treat neuromyelitis optica spectrum disorder, a rare, severe, relapsing, neuroinflammatory autoimmune disease.

In other European biosimilar news, Gedeon Richter launched its biosimilar teriparatide, Terrosa, in Europe. The drug, referencing Eli Lilly’s Forsteo, is used to treat osteoporosis. The product will also be sold under the brand name Movimya by the company’s partner, Stada. Meanwhile, US patients with osteoporosis are likely to see only follow-on versions of teriparatide become available to them; teriparatide is not on the FDA’s preliminary list of products that will transition from regulation as drugs to regulation as biologics in 2020.

Elsewhere, other regulatory territories saw the launches of new biosimilar products; Mylan and partner Biocon launched their biosimilar trastuzumab, Ogivri, in Australia, where the product is now listed on the nation’s Pharmaceutical Benefit Scheme. And in India, Dr. Reddy’s Laboratories launched Versavo, a biosimilar bevacizumab product.