Cinfa Biotech S.L. announced positive top-line data from the second clinical trial of its lead development candidate B12019, a biosimilar of Amgen’s pegfilgrastim (Neulasta) to treat chemotherapy-induced neutropenia. The company announced that the randomized, double-blind, 3-period crossover study demonstrated that B12019 was comparable to its reference product with respect to pharmacodynamics (PD) and immunogenicity.
The study, conducted in 96 healthy volunteers in Germany, was based on specific advice from the European Medicines Agency (EMA), and was tailored to the specific properties of pegfilgrastim. The primary end points, area under the effect curve for PD, and anti-drug antibody rate (ADA) for immunogenicity, confirmed comparability to the originator product. All secondary end points were achieved and B12019’s safety profile was found comparable to the reference pegfilgrastim, the company said. Further trial data are to be presented at upcoming scientific meetings.
Headquartered in Pamplona, Spain, Cinfa Biotech, expects to make a Marketing Authorization Application (MAA) submission for B12019 with the EMA in the second half of 2017. Ruediger Jankowsky, PhD, managing director of Cinfa Biotech, said these positive results from the company’s second study confirm the biosimilarity of B12019 and the reference pegfilgrastim, which were also demonstrated in the first trial. “Both studies, together with the analytical and functional comparability data, support the high quality of our product candidate,” said Jankowsky.
Several biosimilar developers have tried to obtain approval for proposed biosimilar versions of pegfilgrastim, a long-acting version of filgrastim (Neupogen), also manufactured by Amgen, but have faced hurdles in both the US and Europe. Biosimilars of Neupogen have been on the market for years in Europe, and Sandoz’s biosimilar of Neupogen, Zarxio, was the first a biosimilar approved in the United States and was marketed in 2015. But Neulasta is a bigger, more complex biologic, and biosimilar makers have not yet had a pegfilgrastim biosimilar approved by the EMA or the FDA.
In the United States, 2 manufacturers of candidate pegfilgrastim biosimilars are being sued by Amgen: the company filed a legal action in California state court against biosimilar maker Coherus in March 2017 alleging that Coherus had engaged in a “massive conspiracy” to steal Amgen’s trade secrets for Neulasta. Claiming the lawsuit is without merit, Coherus said it is an effort by Amgen to delay competition in the pegfilgrastim market. Coherus’ biosimilar to pegfilgrastim (CHS-1701) is scheduled for a June 9, 2017, regulatory hearing at FDA.
In a separate legal action, Amgen filed a preliminary injunction against Canadian biosimilar maker Apotex, seeking to prevent the company from giving Amgen the required 180-day notice of marketing of its proposed pegfilgrastim biosimilar until after Apotex gets FDA approval, which has not yet occurred. (Apotex’s pegfilgrastim biosimilar candidate was accepted for FDA review in December 2014.) Amgen’s position on notice was upheld by the US District Court as well as the Federal Circuit Court on appeal. The US District Court did hold that Apotex had not infringed on patents that Amgen had challenged; that decision is being appealed by Amgen. The US Supreme court denied Apotex’s request for review of the District Court decision.
There is another potential pegfilgrastim candidate in the pipeline. In February 2017, the FDA accepted Mylan/Biocon’s proposed pegfilgrastim biosimilar (MYL-1401H) for review. The FDA’s goal for a decision on the application, based on the User Fee Act, is October 9, 2017.