South Korean billionaire and chairman of Celltrion Group Jungjin Seo is returning Celltrion Inc. to its contract manufacturing organization (CMO) roots, as it relies on biosimilar sales to anchor the company in a fiercely competitive novel drug R&D arena.
Shares of Tharimmune Inc. shot up more than 100% in early trading Oct. 30 as the firm disclosed regulatory backing to launch a phase II trial this quarter testing TH-104, a transdermal buccal film version of nalmefene, to treat pruritus that is associated with primary biliary cholangitis.
If the maximum fair prices the U.S. CMS announced after the first round of drug price negotiations are any indication, advocates of the government price setting may be settling for short-term wins at the cost of long-term, more sustainable price reductions driven by competition.
Samsung Bioepis Co. Ltd. and Celltrion Inc. are making headway in Europe and U.S. with respective follow-on biologic products, with Samsung Bioepis the latest to gain EMA approval for Pyzchiva, a Stelara (ustekinumab, Janssen Pharmaceuticals Inc.) biosimilar, on April 23.
Biologics innovators typically take a lifecycle approach to developing new indications and formulations of their prescription drugs, especially when biosimilar competition is on the horizon.
With the biggest biosimilar launch in the U.S. just days away, Humira’s (adalimumab) record-breaking ride is quickly slowing down, but the Abbvie Inc. mega-blockbuster immunology drug is nowhere near the end of its road. Meanwhile, the U.S. journey is just beginning for the eight adalimumab biosimilars that could come to market as early as July 1 through licensing agreements with Abbvie. Besides revving their engines against Humira, the new launches will be looking to overtake Amgen Inc.’s biosimilar, Amjevita, which got a five-month headstart in the U.S., thanks to the first-mover status Amgen earned for being the first to sign a licensing agreement with Abbvie.
Even though the EU had approved more than a dozen biosimilars by 2012, the follow-on biologics were still in their embryonic stage around the world when BioWorld published The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies in early 2013. Now, nearly a decade later, the global biosimilar landscape has matured with many more biosimilars approved across the globe, but the uptake, and thus the savings, is not what some policy makers and people in industry had hoped for or expected.
Although broader use of biosimilars in the U.S. would reduce Medicare Part D spending and save beneficiaries nearly $2 million in out-of-pocket costs, plan formularies continue to discourage the use of the more affordable follow-ons, according to a recent report from the Department of Health and Human Services’ Office of Inspector General.
More than a decade after the Biologics Price Competition and Innovation Act became law and nearly six years after the first biosimilar launched in the U.S., the country’s first potential interchangeable is on deck awaiting an FDA decision.
With the next big wave of biologic patent expirations soon to wash over the U.S. market, companies developing biosimilars are optimistic about the future. “We’re at a place where we’re seeing really strong uptake of biosimilars, which has resulted in cost savings,” Chad Pettit, executive director of marketing for Amgen Inc.’s biosimilars unit, told BioWorld.
