Business

Just last month, the European Commission authorized a subcutaneously administered formulation of biosimilar infliximab CT-P13 for the treatment of rheumatoid arthritis. When the drug launches in the European Union, it will be first infliximab to be available in a subcutaneous formulation. This week on the podcast, we’re speaking about this new product with Mike An, head of the sales and operations division at Celltrion Healthcare. 
Israel-based Kamada Ltd announced this week that it has entered into an agreement with Iceland-based Alvotech to commercialize 6 biosimilar products in Israel once the products gain local regulatory approval.
The FDA has approved Amgen’s infliximab biosimilar, Avsola (infliximab-axxq), referencing Remicade.
The Center for Biosimilars® recaps the top stories for the week of December 2, 2019.
Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, said this week that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application to initiate a phase 1 clinical study to compare the pharmacokinetics and safety of BAT2206, a proposed ustekinumab biosimilar, to the reference Stelara in healthy volunteers.
While there is no question that falling prices that come with competition are cause for optimism in the United States, which is burdened by rising drug costs, some experts from Europe caution that a focus on price alone misses key reasons to use biosimilars.
Amgen and pharmacy benefit manager (PBM) Abarca this week announced that they have entered into an outcomes-based contract for brand-name etanercept, Enbrel.
Trade representatives for Canada and Mexico met last week over the ratification and implementation of the United States–Mexico–Canada Agreement (USMCA), and press reports say that the Trump administration is considering acceding to Democrats’ demands to reduce patent protections for reference biologics in order to get the pact through Congress.
HR 3 proposes targeting for negotiation those drugs that consume a large share of the healthcare budget and that have limited biosimilar or generic competition. Writing in a perspective article in The New England Journal of Medicine, Peter B. Bach, MD, MAAP, a noted critic of high drug prices, proposed a different set of targets.
With debate and argument over what is to blame for high drug pricing, this report sought to examine the executives’ reasoning and attitudes behind pricing decisions.

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