Generics

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.

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.

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.

Lupin has added two ADHD drugs to its Canadian portfolio, while also signing multiple branded deals in other global markets.

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.

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.

The world’s best-selling diabetes medicine, with sales last year across the globe of around $14bn, is now in the crosshairs in the US for Viatris’ Mylan and its partner Natco, after the firms announced an agreement settling litigation that was pending before the US Patent and Trademark Office’s Patent Trial and Appeal Board.

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.

Alkem and Torrent said the tested batches were not manufactured by them, as a recent CDSCO report pinned their drugs as “not of standard quality”. Meanwhile, other firms informed the agency themselves about counterfeit drugs on the market.

A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.

As Sandoz publishes a report on US drug shortages – dissecting their root causes, the current policy landscape and recommendations for future improvements – the firm’s North America head and AAM chair Keren Haruvi speaks to Generics Bulletin about what can be done to alleviate continuing supply-chain failures.

Biogen resorted to using unlawful, anticompetitive agreements to block the distribution of generic Tecfidera, while it scrambled to switch the market to its follow-on brand, according to another class action lawsuit brought against the originator.

Teva has begun shipping the first US generic version of Novartis’ Sandostatin LAR Depot – a synthetic polypeptide that is part of a difficult-to-manufacture class of long-acting polymers.

Iconovo’s efforts in bringing its Breo Ellipta rival to the market continue, with positive news received from the FDA on the substitutability of the firm’s ICOpre proprietary inhaler. The firm is now seeking a partner to take the product to the next stage.

Generics Bulletin previews the most notable and anticipated events for October 2024.

Biocon has struck a deal that will see its GLP-1 diabetes and chronic weight management products commercialized in the Middle East region by partner Tabuk Pharmaceutical.

Generics Bulletin recaps the most recent regulatory news from across the world.

In a closely anticipated US Senate Committee hearing, Novo’s CEO was grilled by US senator Bernie Sanders and others on the high price of Ozempic and Wegovy in the country.