Amgen is none too eager for Novartis to roll out its newly FDA-approved biosimilar version of its blockbuster Neupogen, and for now, it's getting its way: A U.S. appeals court has blocked sales of the copycat while the companies resolve a patent dispute.
Nearly a dozen makers of biosimilars, including Hospira, Pfizer, Samsung and Sandoz, have banded together into the Biosimilars Forum, a nonprofit group that will lobby for how biosimilars are used in the U.S.
Conventional thinking is that the complexity of biosimilars will keep their discounts to just 20% to 30% of the branded price. Think again. In Norway a biosimilar of Merck's arthritis blockbuster Remicade is going for a discount of nearly 70%, upsetting conventional wisdom and competitors.
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.