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.
Biotech companies and biosimilars makers have been squabbling for years about the way the lower-cost copies will be prescribed and distributed. Brand makers wanted to raise hurdles to replacing their meds with biosimilar versions. But now, with biosimilars nearing their U.S. debut, the two sides have reached a compromise.
As drug prices climb and expensive newcomers inspire payers to get creative to contain costs, a window is widening for meds that can drive efficiency for healthcare systems and address consumers' needs. That's where biosimilars come in--or so Pfizer figures.
Biosimilars are in high demand, and Pfizer is looking to cash in on the trend with copycat meds that drive efficiency for healthcare systems and address consumers' needs, Diem Nguyen, general manager of Pfizer's Biosimilars, told FiercePharmaMarketing.
The biosimilar bonanza is underway, and Johnson & Johnson's rheumatoid arthritis drug Remicade is at the center of the copycat action. Boston-based biosimilar maker Epirus Biopharmaceuticals is rolling out a knockoff of the monoclonal antibody (mAb) in India with partner Ranbaxy Laboratories, a year after Hospira got its Remicade version approved in Europe.
The patent provisions of the Hatch-Waxman Act are familiar to both sides of the branded-generic fence by now. Not so when it comes to similar procedures related to biosimilars. In fact, as a lawsuit over Sandoz's knockoff version of the Amgen therapy Neupogen shows, the two sides don't even agree on the rules.
The market for Humira is a large one: the med raked in $11.02 billion last year to top the list of the world's best-selling drugs. So it's no surprise that biosimilar developers are going after a piece of that market--including Amgen, which released some head-to-head data last week that could help it make its regulatory case.