June 25, 2022
The European Committee for Medicinal Products for Human Use (CHMP) recommended 2 biosimilars for approval: Celltrion Healthcare’s bevacizumab candidate and Formycon’s prospective ranibizumab product.
June 24, 2022
June 23, 2022
June 22, 2022
June 21, 2022
As drug companies continue to follow the growing trend adopting more environmentally friendly and socially conscious frameworks, many are choosing to highlight their biosimilar portfolios as an example of their efforts.
The Federal Trade Commission (FTC) will require the 6 largest pharmacy benefit managers (PBMs) to submit records and answer questions regarding their business practices.
May brought a number of biosimilar policy updates of all types, including updates on British Columbia's switching program, a new bill that could revamp biosimilar user fee programs, and more.
June 20th 2022
By Skylar Jeremias
Not long after the company announced its new global initiative to promote access and increase adoption of biosimilars, Sandoz’ biologics license application for its high-concentration adalimumab biosimilar was accepted by the European Union’s regulatory agency for review.
June 19th 2022
The Biden administration must follow through on its promises, and Congressional leaders must do more to push through bipartisan biosimilar policies to encourage better adoption and lower drug costs, according to Julie M. Reed, the executive director of the Biosimilars Forum.
June 18th 2022
By Deana Ferreri, PhD
A financial evaluation study proposed a framework for choosing which biosimilar candidates companies should develop, a process that requires a detailed and careful analysis to ensure that the candidate will be successful in global biopharmaceutical markets.
June 17th 2022
Here are the top 5 biosimilar articles for the week of June 13, 2022.
June 16th 2022
Abstracts from the American Society of Clinical Oncology (ASCO) annual meeting took a look at the impact biosimilar substitution and increased biosimilar adoption had on spending within practices participating in value-based payment models and the Oncology Care Model.
June 15th 2022
Iceland-based Alvotech announced that the pureplay biosimilars company is debuting on the public market starting June 16.
By Ivo Abraham, PhD
Ivo Abraham, PhD, chief scientist of Matrix45 and a member of The Center for Biosimilars® Advisory Board, explores the complicated world of phase 3 trials for biosimilars to answer the question of whether they are truly needed for establishing biosimilar safety and efficacy.
June 14th 2022
The FDA granted a new indication for rheumatoid arthritis for Riabni, a rituximab biosimilar, and Organon and Shanghai Henlius Biotech entered into a licensing agreement for 2 oncology biosimilar candidates.
June 13th 2022
An analysis of retrospective data demonstrated comparable safety and efficacy profiles between CT-P6, a trastuzumab biosimilar, and Herceptin (reference trastuzumab) combined with chemotherapy and pertuzumab.
June 12th 2022
Gillian Woollett, MA, DPhil, vice president and head of regulatory strategy and policy at Samsung Bioepis, outlines how concerns over the safety and efficacy of biosimilars has shifted and what new concerns the industry is focusing on.
