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April 13, 2022
Article
Amneal said the product, to be sold under the name Alymsys, is the second of 3 US biosimilars the company expects to see approved this year.
July 03, 2020
Article
A recent opinion column outlines some principles to consider when thinking about changing the current US system of financing drug innovation, especially potentially curative therapies.
July 02, 2020
Article
Sandoz said it was reviewing all options, including a possible appeal to the Supreme Court. The case concerns Amgen's originator drug Enbrel and the biosimilar Erelzi.
June 27, 2020
Article
Patients have problems getting timely authorizations for specialty meds and physicians face time burdens in getting them approved, a new report from CoverMyMeds says.
June 24, 2020
Article
The UK results show how challenging switching to a biosimilar can be, according to patient groups.
June 22, 2020
Article
The judge in the Humira case, while noting that the patents have made it nearly impossible for rivals to gain a foothold, said the suit did not constitute a valid antitrust claim.
April 13, 2020
Article
Cancer treatments can lead to unpredictable adverse events, so a COVID-19–related measure allowing home infusion jeopardizes patient health and safety, according to the Community Oncology Alliance (COA).
March 05, 2020
Article
Looking to March 23, the FDA released a question-and-answer guidance document for industry about the upcoming transition for how certain products will now be approved under a biological pathway, including exceptions to the transition and how companies will receive notifications about their applications.
February 25, 2020
Article
The guidelines, based on clinical evidence, are a pathway to a shared decision-making process between patients and their physicians, said the American College of Rheumatology (ACR).
February 21, 2020
Article
The FDA said it was no longer necessary to include the interpretation of the term “chemically synthesized polypeptide” as first proposed in December 2018.