Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, ...

As this example shows, a long path lies between any approved biological drug and creating a biosimilar that can be used in patients.

In this episode of Not So Different, host Skylar Jeremias covers the latest biosimilar developments, including new FDA ...

SMi Group Reports: Following the FDA’s release of a Biosimilar Action Plan, this year’s Biosimilars USA conference promises to explore the developments in biosimilar drug development During a ...

Less than a decade since it secured its first FDA approval for a biosimilar, Amgen’s portfolio of the copycat drugs is growing and making strong contributions to the company’s top line.

The US Food and Drug Administration (FDA) has approved Avtozma (tocilizumab-anoh) as a biosimilar of the original reference biologic tocilizumab (Actemra), according to a January 30 announcement ...

Accord BioPharma Inc., the U.S. specialty division of Intas Pharmaceuticals Ltd., has reached an exclusive commercialization and license agreement with Bio-Thera Solutions for BAT2506, a biosimilar ...

Ablynx is looking for new partners to take its rheumatoid arthritis drug vobarilizumab ... to trial design and location,” Ablynx said. The FDA has approved Amgen’s cheaper Humira biosimilar ...

Dr. Reddy's (RDY) partners with Shanghai Henlius Biotech to develop and market biosimilar versions of J&J's (JNJ) multiple ...

Samsung Bioepis and Teva have entered into a license, development and commercialization agreement for Epysqli (eculizumab-aagh), which is Samsung Bioepis’s biosimilar to Soliris. Samsung Bioepis ...

Tocilizumab-anoh is the seventh biosimilar by Celltrion to receive FDA ... responses to at least 1 disease-modifying antirheumatic drug (n = 471) to receive 8 mg/kg of CT-P47 or reference ...