FDA approves Pfizer’s epoetin alfa biosimilar Retacrit
The Food and Drug Administration on Tuesday approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa).
The biosimilar, from Pfizer’s Hospira was approved for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.
“It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products,” stated Leah Christl, director of the Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research. “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”
Pfizer said that it would be working with Vifor Pharma on commercialization in certain channels for Retacrit — the company’s third approved biosimilar in the United States. The lower-cost alternatives to branded biologic drugs — which are not interchangeable products — are set to play a big role in the Trump Administration’s plan to lower drug prices.
“As the first approved epoetin alfa biosimilar in the United States, Retacrit may provide patients and their physicians with increased access to a high-quality, lower-cost alternative treatment option for anemia and the reduction of allogeneic red blood cell transfusions in certain patients,” said Berk Gurdogan, U.S. institutions president at Pfizer Essential Health. “We are proud of the progress of our biosimilars program to date, which will help address the evolving needs of patients and the broader healthcare community.”
Aquestive Therapeutics settles patent infringement case with Par Pharmaceuticals
WARREN, N.J. — Specialty pharmaceutical company Aquestive Therapeutics has reached a settlement agreement resolving patent litigation related to Suboxone (buprenorphine and naloxone) Sublingual Film.
Indivior, a marketer and distributor of Suboxone, joined Aquestive in the settlement with Par Pharmaceuticals, an operating company of Endo International and IntelGenx Technologies Corp.
Under the settlement agreement, Par Pharmaceuticals and IntelGenx agreed to launch their proposed generic version of the buprenorphine and naloxone sublingual film no earlier than Jan. 1, 2023. The patent-infringement litigation has been pending in the U.S. District Court for the District of Delaware. As required by law, the parties will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
“This settlement once again demonstrates the value our intellectual property and know-how represent for us and our partners,” stated Keith Kendall, CEO of Aquestive. “We will continue to focus our PharmFilm technology platform on innovating within difficult disease states such as epilepsy, Parkinson’s and ALS.”
Adello Biologics names Amneal co-chairman as CEO
Adello Biologics, a U.S.-based biotechnology company headquartered in Piscataway, N.J., has named Chintu Patel as CEO, effective immediately. Patel succeeds Peter Moesta, who is stepping down to pursue other opportunities.
Most recently co-CEO, co-chairman and co-founder of generic pharmaceutical company Amneal Pharmaceuticals, Patel is now a co-chairman of the Amneal board of directors.
“I am delighted to lead a team of distinguished scientists and professionals at Adello,” said Patel. “Together, we will harness the extraordinary potential of the biosimilars market and transform Adello into a world-class healthcare company that develops important, affordable, accessible medical treatments. I would like to thank Peter for his contributions to advancing Adello’s lead biosimilar candidates towards registration. I wish him the best of luck in his new endeavors.”
Patel has more than 20 years of experience within the industry, beginning with his career at Eckerd Pharmacy. He has been recognized by his peers on numerous occasions, including the 2011 Ernst & Young National Entrepreneur of the Year Life Sciences Award. He has been a featured speaker at the Hauppauge Industrial Association of New York and serves on the boards of the Long Island Association and the Make-a-Wish Foundation. With his wife, Falguni, Patel created the Irada Foundation, focused on health and education issues.
He holds a Bachelor’s degree in pharmacy from Rutgers College of Pharmacy and an honorary Doctor of Science from Long Island University.