Celltrion has set its sights on shipping a less expensive version of rheumatoid arthritis drug Remicade to the U.S. in the third quarter, pending approval from the FDA.
Colorado's house of representatives passed a bill allowing pharmacists to substitute biosimilar versions of biotech drugs, even when the brands are prescribed by name. The approach would almost mirror the substitutions allowed with standard generic meds, except for the fact that pharmacists would be required to notify doctors about the change.
It's been a long, long regulatory road, but the first FDA-approved biosimilar--a copy of Amgen's Neupogen from Novartis' generics unit, Sandoz--is finally here. But that doesn't mean it'll catch on right away, as the Swiss pharma's CEO has been first to admit.
The FDA accepted Apotex's application to copy an Amgen blockbuster, giving the Canadian drugmaker a chance to cash in on the coming biosimilar boom in the U.S.
South Korea's Samsung BioLogics has pledged to be a big deal in biosimilars, but so far its biologics subsidiary has produced mostly operating losses for its parent. In anticipation of turning that around, the company will undertake a significant expansion of the biologics plant in Songdo, Incheon, that it opened in 2013.
Bangladesh's pharmaceuticals industry has become a $1.5 billion business producing 97% of the nation's consumption, but it has a long way to go in various segments including exports, according to Shawkat Haider, general manager of Beximco Pharmaceuticals.
China biotech Innovent's recent success in raising $100 million in venture capital to help it build a pipeline of biosimilars could be a signal of how the industry may be set to explode in a country about to invest $6.45 billion in startups.
Innovent Biologics has raised $100 million in venture cash in hopes of becoming the premier maker of biotech drugs in its native China, advancing a pipeline of biosimilars and proprietary treatments.
A group of FDA advisers unanimously recommended approval for Novartis' knockoff of a blockbuster Amgen treatment, clearing the way for what would be the first U.S. approval of a copycat biologic medicine.
Those looking for a window into the FDA's thoughts on biosimilars got their first direct peek Monday. The agency released briefing documents for an upcoming panel meeting on Novartis' biosimilar of Amgen's Neupogen. The takeaway? The FDA seems to be softpedaling on whether the biosim is "interchangeable" with Neupogen itself, allowing approval to be based on biosimilarity instead.