The Center for Biosimilars Staff

March 21, 2020

Kashyap B. Patel, MD, has worn many hats in the struggle to broaden biosimilar access. He is an independent oncology practitioner, a member of the Community Oncology Alliance (COA), and a representative of International Oncology Network (ION) Solutions, a large drug purchasing organization. Bringing biosimilars to a broader population of patients has involved negotiations with payers, persistence on Capitol Hill, and education, he explains in an interview.

March 03, 2020

The Supreme Court will hear an appeal by a coalition of 20 mainly Democratic states, which are hoping for a reversal of a Fifth Circuit Court of Appeals ruling that held the Affordable Care Act’s (ACA) individual mandate is unconstitutional and called into question whether the remaining provisions of the law could still stand. However, a decision will not come until after the November 2020 presidential election.

February 26, 2020

Antitrust claims are a product of federal statute, said the Third Circuit Court of Appeals, in reinstating a Walgreens and Kroger antitrust lawsuit against J&J over its branded infliximab, Remicade.

February 19, 2020

The review found no increased risk of cancer when looking at both keratinocyte cancer and lymphomas in patients on biologics vs conventional therapy. Overall, however, patients with psoriasis appear to have a slightly increased risk of certain cancers.

February 06, 2020

Bio-Thera Solutions announced that a phase 3 clinical trial comparing the efficacy and safety of its bevacizumab biosimilar, BAT1706, to the reference product (Avastin), returned positive top-line results.

January 29, 2020

The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products under the biosimilar approval pathway.

January 29, 2020

The documents include specific ones for hemophilia, retinal disorders, and rare diseases, as well as manufacturing, testing, and patient follow-up.

January 24, 2020

Pfizer said it expects its 3 oncology biosimilar products to have the lowest wholesale acquisition cost among currently available bevacizumab, rituximab, or trastuzumab biosimilars. Its latest, Ruxience, referencing Rituxan, launched Thursday.

January 22, 2020

Health New England says it achieved 93% utilization by requiring prior authorization.

January 17, 2020

The current market value of the branded sales for these biosimilars is estimated to exceed $2 billion annually, the companies said.