In the wake of its recent acquisition of dermatology assets from Canute Pharma, UK-based Aspire Pharma is looking to new frontiers of expansion in Europe and beyond. Chief executive Richard Condon talks to Generics Bulletin about the next steps on the niche generics and value added medicines firm’s journey.
Sponsors of generic drug applications that miss a goal date, but do not receive an action because of complex scientific or legal questions, would get a notice outlining the lingering issue as part of a new pilot program that might become permanent in the next review cycle.
Respondents to the FDA’s questions over biosimilar development did not hold back. So, what is it: product-specific or product class-specific guidance? Or nothing?
Teva has been fined €463m – just over half a billion US dollars – over a breach of EU antitrust rules, after the European Commission found that it abused its dominant position to delay competition to Copaxone, including by misusing the patent system and disparaging rivals. The firm has strongly disagreed with the decision – which is claims is “legally untested” and “not supported by the facts” – and says it will appeal.
In a citizen petition to the FDA, Alvotech has called on the US agency to refrain from approving as interchangeable certain Stelara biosimilars that use a different cell line to its own ustekinumab product – including the Pyzchiva version set to be brought to market by Samsung Bioepis and Sandoz.
After sharing multiple updates to the regulatory status of its ketamine formulation, PharmaTher received a complete response letter from the FDA, which required minor information and clarifications from the company.
Only a month after filing their second biosimilar application with Japanese regulators, Alvotech and Fuji have submitted a further one for an undisclosed biosimilar as part of their local partnership.
French industry association Gemme has issued a stark warning that recent legislative proposals – including a revision to the country’s clawback mechanism and steeper financial penalties for failing to hold sufficient safety stocks – will “bring about the end of the generic economic model in France.”
With a looming deadline of 1 January 2025 for firms supplying Northern Ireland to comply with the Windsor Framework, UK generics and biosimilars association the BGMA has warned of potential supply interruptions due to requirements that include a “UK only” label for all packs as well as UK-based batch testing for biologicals.
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.
The wait for US competition to AbbVie’s Lumigan 0.01% glaucoma brand, launched more than a decade ago, goes on, after Mankind bowed to infringement of a key US patent.
A watershed moment is on the horizon for US biosimilars, with Amgen looking poised to debut competition to Eylea (aflibercept).
With sales projected to peak at nearly $700m a year, Galafold – the first oral monotherapy for people living with the ultra-rare genetic disorder Fabry disease – is a lucrative target for ANDA sponsors. However, Teva, which has just put pen to paper on a patent-litigation settlement agreement, will have to wait more than a decade to roll out its generic product.
