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biosimilars

Latest Headlines

Latest Headlines

Innovent's $100M deal signals how biotech is ready to explode in China

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.

China's Innovent banks $100M to cash in on the biosimilar boom

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.

Novartis clears an FDA hurdle with its pioneering biosimilar of Amgen's Neupogen

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.

FDA reviewers back Novartis biosim of Amgen's blockbuster Neupogen

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.

To substitute or not to substitute? Biotechs and biosim makers compromise on legislation

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.

Pfizer believes a dose of confidence will help it sell biosimilars

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.

Pfizer believes a dose of confidence will help it sell biosimilars

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.

Epirus and Ranbaxy launch a Remicade biosimilar in India

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.

Amgen-Sandoz squabble over Neupogen copy could reshape biosim marketing

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.  

Can Amgen's marketing muscle vault its Humira biosim ahead of rivals?

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.