November 15th 2019
By Allison Inserro
A House subcommittee voted unanimously Thursday to send a bill intended to stop sham citizen petitions from clogging the FDA’s approval process for generic drugs under the section 505 pathway to the full Energy and Commerce Committee.
November 14th 2019
By The Center for Biosimilars Staff
The World Health Organization (WHO) this week announced its pilot procedure for the prequalification of human insulin as means to facilitate access to safe, effective, and quality-assured insulin and insulin biosimilars for type 1 and type 2 diabetes in low- and middle-income countries.
November 12th 2019
By Kelly Davio
Improvements in biosimilars—ones that may give them an advantage such as lower immunogenicity or a new route of administration—may be the key to unlocking a better patient experience, according to Celltrion. In fact, pursuing such so-called “biobetters” may prove to be more important for the drug maker than pursuing interchangeable biosimilars.
November 8th 2019
The Center for Biosimilars® recaps the top stories for the week of November 4, 2019.
November 7th 2019
Teva and Celltrion have announced the launch of their biosimilar rituximab, Truxima, in the United States. The product is being offered at a 10% discount to the list price of reference product, Rituxan. The product will begin to reach patients on November 11.
November 6th 2019
The FDA has issued an establishment inspection report (EIR) for Biocon’s Bengaluru facility, where the drug maker manufactures biosimilars, and the FDA’s inspection of the facility, which took place during August 2019, is now closed.
November 5th 2019
The FDA has approved Ziextenzo (pegfilgrastim-bmez), Sandoz’s biosimilar pegfilgrastim referencing Neulasta. The biosimilar was approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive anticancer treatment. Sandoz plans to launch the product this year.
November 4th 2019
On Friday, President Donald Trump announced that he intends to nominate Stephen Hahn, MD, FASTRO, to be the next FDA commissioner.
October 31st 2019
A bipartisan bill introduced in the Senate this week aims to address the growing issue of drug shortages.
October 30th 2019
Given how markets operate, pharmaceutical companies need financial incentives in order to keep providing a reliable stream of high-quality products that otherwise, due to low prices and other factors, might fall into shortage, according to an FDA report about the drug shortages problem released this week.
