USV Announces Positive Clinical Study Data for Pegfilgrastim Biosimilar Candidate

USV, a Mumbai-based pharmaceutical company, announced on Thursday that it had successfully completed phase 1 and phase 3 studies on a proposed pegfilgrastim biosimilar referenced on Neulasta. The company expects to submit data for its marketing authorization application to the European Medicines Agency before the end of 2017.

The phase 1 studies, which compared the pharmacokinetics and pharmacodynamics of the biosimilar with the reference product at a therapeutic dose and at a low dose, per European Union guidelines, met their primary endpoints.

The phase 3 study involved 254 patients who were scheduled to undergo chemotherapy for the treatment of breast cancer. The patients were randomized to receive either the biosimilar candidate or the reference product 24 hours after the administration of myelosuppressive chemotherapy. USV reports that its product demonstrated comparable safety and efficacy to the reference drug, and that the incidence of adverse events was comparable between the 2 treatment groups.

As of August 4, 3 other pegfilgrastim candidates were under review by the Committee for Medicinal Products for Human Use (CHMP). However, pegfilgrastim biosimilars have had difficulty reaching approval for the European marketplace; earlier this month, Biocon withdrew its application for a pegfilgrastim biosimilar as the company’s manufacturing facility awaits re-inspection. In January, Sandoz withdrew its application for a marketing authorization for its product, Zioxtenzo, telling the European Medicines Agency (EMA) that it would not be able to provide the additional data that the agency had requested within the allowed timeframe. In 2016, Gedeon Richter withdrew its applications for authorization to market its pegfilgrastim candidate as 2 products, Efgratin and Cavoley, after the CHMP issued a negative provisional opinion.

Biosimilars of pegfilgrastim have not fared much better in the US regulatory sphere. Sandoz’s drug was rejected by the FDA in 2016, and Coherus received a complete response letter for its attempt at a biosimilar, CHS-1701, in June. Coherus has vowed to continue development of the drug, and is currently engaged in patent litigation with Amgen, maker of Neulasta.

Two additional proposed biosimilars are currently under FDA review; Apotex announced that the FDA had accepted its filing for its product in 2014, but no regulatory action has yet been taken on the product. Biocon’s product also remains under FDA review, though it is unclear whether the issues with the company’s facility that prompted a withdrawal of its EMA application could impact the FDA’s verdict on the drug, which is expected by the Biosimilar User Fee Act date of October 9, 2017.