The Center for Biosimilars Staff

February 12, 2019

A recent study looked at the long-term stability of CT-P6, a trastuzumab biosimilar referencing Herceptin, to see if it had the same stability as the reference product.

February 12, 2019

In a long-running patent dispute with biosimilar developer Boehringer Ingelheim, AbbVie, maker of the brand-name adalimumab, Humira, has been ordered to produce documents related to its efforts to obtain patents that could shield its blockbuster drug from biosimilar competition.

February 11, 2019

Biosimilar developer Samsung Bioepis, a partnership between Samsung BioLogics and Biogen, has announced a new licensing agreement with the private equity firm C-Bridge Capital that will allow the drug maker to expand its reach into mainland China.

February 08, 2019

The FDA recently released final guidance on the use of therapeutic proteins in developing biologics and biosimilars. "Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection" represents current FDA thinking about developing and validating assays for anti-drug antibody (ADA) detection.

February 08, 2019

This week, the United States Court of Appeals for the Federal Circuit found that Momenta lacked standing to appeal a decision upholding a patent covering abatacept (Orencia) and said that Momenta’s appeal was rendered moot by the drug makers’ choice to stop developing its biosimilar.

February 06, 2019

Some stakeholders have welcomed the proposed rule to bar drug makers from giving pharmacy benefit managers rebates, while others raised serious concerns.

February 05, 2019

Mundipharma announced today that it has launched Pelmeg, a biosimilar pegfilgrastim referencing Neulasta, in Germany, the Netherlands, and Ireland.

February 04, 2019

In a newly published correspondence, Italian rheumatology providers called into question whether recently published results from the DANBIO registry can be used to guide non-medical switching from reference etanercept (Enbrel) to biosimilar SB4 (Benpali) in patients with inflammatory diseases.

January 27, 2019

Bio-Thera Solutions, a China-based biosimilar developer, announced that it has dosed the first patients in its phase 3 clinical study of BAT1806, a proposed biosimilar tocilizumab referencing Actemra, an interleukin-6 inhibitor.

January 26, 2019

A new report out this week found that increases in insulin spending were primarily driven by increases in insulin prices and, to a lesser extent, a shift toward use of more expensive analog insulins.