Biocon Biologics chief commercial officer for advanced markets Matt Erick says the firm is a “quiet giant” in the biosimilars space, but speaks up about the firm’s plans to grow its business in Europe, explore in-licensing as well as in-house development, and capitalize on the upcoming loss of exclusivity for Stelara in the US.
With the UK generics market facing a rising number of supply issues, local off-patent industry association the BGMA has put forward a raft of policy proposals that it said could provide solutions.
The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers.
The proposed CMS innovation center's $2 drug list model will not address the barriers to newer generics getting on Part D formularies and plans may have little incentive to participate in the demo, an industry group said.
Teva has resolved a pair of civil US Department of Justice lawsuits accusing the firm of violating the US Anti-Kickback Statute and the False Claims Act through its alleged conduct conspiring to fix the price of three generic drugs and for allegedly paying Medicare patients’ copays for its multiple sclerosis brand Copaxone.
The US FTC and FDA both received letters from the Senate but with different messaging. One commends for achieved findings and requests a new investigation and another scalds for not doing the assigned job.
Japan has started to charge patients a portion of the difference between the reimbursement price of the generic and non-generic product if they insist on the latter without a supporting recommendation from the prescribing physician, in a policy designed to further drive generic use.
A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
Generics Bulletin reviews several critical US bills and the off-patent industry’s response, along with budget calculations and new proposals.
Hyloris recognized that the suspension of its shares as part of a broader business fallout has “created uncertainty and temporarily impacted management and organizational focus,” as it got another commercial deal over the line for its Maxigesic IV (paracetamol/ibuprofen) solution for infusion.
Sandoz, Adalvo and Eurofarma were the biggest winners at the Global Generics & Biosimilars Awards 2024, each taking multiple honors, among the many champions named across 14 separate categories at our prizegiving ceremony in Milan.
Aspire Pharma has bolstered its dermatology portfolio by striking a deal to acquire “all assets” of another UK-based player, Canute Pharma.
Generics Bulletin previews the most notable and anticipated events for October 2024.
In the space of a few days, all four generics manufacturers that had successfully petitioned for a re-examination of a key patent shielding Novo Nordisk’s mega blockbuster Ozempic have reached settlement agreements terminating their challenges.
Fresenius Kabi is facing up to a patent-litigation suit over its proposed biosimilars to Amgen’s Prolia/Xgeva brands – although a prior lawsuit involving biosimilar sponsor Sandoz concluded with a settlement agreement.
The US FTC and FDA both received letters from the Senate but with different messaging. One commends for achieved findings and requests a new investigation and another scalds for not doing the assigned job.
Gilead strikes voluntary licensing agreements with six generic manufacturers for lenacapavir but health groups seek clarity on pricing and seeming API supply restrictions. All eyes are also on the patent opposition case in India.
