Tag:

biosimilars

Latest Headlines

Latest Headlines

Apotex targets Amgen's blockbuster with latest biosimilar app

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.

Bangladesh's drug industry meets nearly all domestic demand, eyes exports

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.

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.