Biosimilar Oncology Roundup: January

The Center for Biosimilars Staff

The early weeks of 2018 held substantial developments for oncology biosimilars in the United States and around the world, with new products on the horizon and evolving challenges in bringing these drugs to the marketplace.

The early weeks of 2018 held substantial developments for oncology biosimilars in the United States and around the world, with new products on the horizon and evolving challenges in bringing these drugs to the marketplace.

A Pegfilgrastim Biosimilar May (Finally) Be Nearing Approval

At the 36th Annual J.P. Morgan Healthcare Conference, Coherus CEO Dennis Lanfear reported progress on the company’s proposed pegfilgrastim biosimilar, CHS-1701. After receiving a Complete Response Letter (CRL) from the FDA in 2017, Coherus is preparing to resubmit its Biologics License Application to the FDA (and to submit a marketing authorization application to the European Medicines Agency). Coherus expects a 6-month FDA review cycle, putting the drug’s potential US approval on track for the third quarter of 2018, as well as potential European approval by mid-2018.

Also at the conference, Rajiv Malik, company president of Mylan, said that Mylan’s pegfilgrastim biosimilar, which received its own CRL from the FDA in October 2017, may be a “mid-year 2018 opportunity” for FDA approval.

The European Union Approves Its First Bevacizumab Biosimilar

After first securing US approval in September 2017, Mvasi, Amgen and Allergan’s bevacizumab biosimilar referencing Avastin, was granted the European Commission’s (EC) marketing authorization this month. The centralized marketing authorization for Mvasi allows the drug makers to sell the biosimilar in the 28 member states of the European Union.

Lawsuits Continue for Anticancer Biosimilars in the United States and Abroad

Biosimilar developers Celltrion and Teva have filed 2 new lawsuits against Genentech, seeking declaratory judgements that 38 patents covering trastuzumab and 37 patents covering rituximab are invalid, unenforceable, or not infringed by the partnership’s biosimilars.

Genentech, for its part, has launched patent infringement lawsuits against Amgen in the United States over alleged infringement of bevacizumab patents, and against Sandoz and Kyowa Hakko Kirin in Japan over alleged infringement of rituximab patents.

Clinical Guidelines Evolve in Brazil

The Brazilian Society of Clinical Oncology released its official position on using biosimilars in practice. Among the recommendations is a call for biosimilars to be treated as interchangeable with their references only under “strict conditions,” with the approval of the prescribing physician, with the full the awareness of the patient, and without “interference from the pharmacist.”

Positive Study Data Announced for 3 Molecules

Pfizer announced positive top-line results for PF-05280586, a proposed rituximab biosimilar, from the phase 3 REFLECTIONS B3281006 study in patients with CD20-positive, low tumor burden follicular lymphoma.

Another rituximab biosimilar, RTXM83, developed by mAbxience, showed similar pharmacokinetics and pharmacodynamics to EU-licensed MabThera in a phase 3 study.

Finally, Samsung Bioepis’ SB3, a proposed trastuzumab biosimilar, demonstrated equivalence with European-sourced Herceptin in terms of breast pathologic complete response rate in patients with HER2-positive breast cancer.

Bringing Biosimilars to US Patients Remains a Challenge

In the most recent Center for Biosimilars® Peer ExchangeTM program, Amanda Forys, MSPH, senior director of reimbursement policy insights at Xcenda, and Christy M. Gamble, JD, DrPH, MPH, director of health policy and legislative affairs at Black Women’s Health Imperative, discussed the challenges of bringing these potentially access-increasing drugs to patients. While stakeholders are all hopeful that biosimilars can bring about cost savings for payers and patients alike, Gamble pointed out that cost is just one factor in terms of patient acceptance:

“[The] conversation comes down to what we call the 5 As of access You have accessibility: is it easy for me to get this medication? Then you have availability: is it available to me immediately? You have accommodation: can I get to it at certain times, can I go to my local pharmacy—my 24-hour pharmacy—and access this drug? Affordability, of course, is key. When it comes to those that are insured, am I able to cover the copay? That’s where cost comes into play. And then acceptability: am I able to get this from my provider, [and] is my provider willing to offer this as an alternative?” said Gamble. “There are so many different things that come into play; cost is just one of them.”