Generics

Despite doubling down on its rare disease ambitions with its Alimera acquisition earlier in July, ANI just announced the second US launch of a generic this month.

The UK’s MHRA has approved the first generic raltegravir to treat HIV in adults and certain pediatric patients and deemed the drug interchangeable with the originator Isentress.

Endo continues to stride its financial revival path, with the latest plans to list common stock on the NYSE. Also, the firm has just launched a generic tiopronin rival to Travere Therapeutics' Thiola.

Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies, securing the supply of generics and biosimilars.

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

An additional week has been added to the deadline for companies to submit their entries for the Global Generics & Biosimilars Awards 2024, ahead of our ceremony in Milan on 9 October.

As she was re-elected as president of the European Commission, Ursula von der Leyen set out plans for the next European Commission that include a Critical Medicines Act to secure the supply chain.

Following on from a flurry of deal and launches, Hikma has released another product onto the US market with the first of its sodium acetate injections, bolstered by 180 days of Competitive Generic Therapy exclusivity. 

The latest UK generic pricing information from WaveData shows multiple products doubling or even trebling their average prices in June.

An FTC report has shown evidence of “troubling rebating practices” between pharma companies and PBMs, lowering access to generics and biosimilars. While off-patent groups commended the agency, the PBM association said the report falls short of being definitive or fact-based.

Manufacturers should keep a sharp eye on data from contract research organizations, looking for “any irregularities” amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.

Latvia’s Olainfarm has rebranded itself as Olpha, setting out its ambitions to become a top 10 pharmaceutical company in Europe and achieve turnover of “at least €1bn over the next ten years”.

Viatris will be able to walk away from years-old US Department of Justice investigations into alleged price fixing, including against its former president Rajiv Malik.

With the UK’s Labour party securing a substantial majority in the country’s general election, the BGMA has spoken to Generics Bulletin about the benefits that it hopes to see from a change in government.

Despite the first and only US FDA approval, Jiangsu Hengrui’s US eVenus has been tipped to stay out of the generic Exparel market until at least the end of the 2030s. Generics Bulletin investigates.

Following on from the recently announced closing of a Saudi Arabia-focused fund, TVM Capital has doubled down on its local efforts with a further $35m investment into Boston Oncology Arabia’s efforts.