Celltrion has reinforced its commitment to the UK by opening a new central operations hub in Uxbridge, while acknowledging that “major questions over the attractiveness of the market” need to be addressed to encourage development and ensure a sustainable environment for UK biosimilars.
As Medicines for Europe gears up for a pair of conferences in Brussels next week, the organization has set out trade policy recommendations to strengthen access to medicines and the competitiveness of EU manufacturing, in a seminar with representatives from the European Commission and member states.
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
As UK players face increasing competitive pressures on “vanilla” generics – including potential new market entrants from China – Ben Ellis, Lupin’s UK and Ireland general manager, explains how the company is focusing on more complex opportunities that require a hybrid generic and branded mindset.
The International Generic and Biosimilar medicines Association has set out three priority areas that it says should be considered by G7 leaders at the current summit in Alberta, Canada, as part of efforts towards ensuring access to health.
Generics Bulletin reviews global regulatory developments across the world.
The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
After multiple past attempts, US legislators have once again proposed a bill that would make all biosimilars immediately interchangeable upon approval. Could a fresh political context help it to succeed this time?
Doubling down on the launch of its Stelara biosimilar Pyzchiva in Europe last year, Sandoz has just released an autoinjectable version of the drug, with the aim to offer a more convenient option for ustekinumab patients.
After signing a deal with Avenacy at the end of last year, Hyloris has now announced the approval of its intravenous formulation of tranexamic acid, which is used as a hemostatic agent.
With entries now open for the Global Generics & Biosimilars Awards 2025 – which takes place in Frankfurt on Wednesday 29 October – Generics Bulletin’s editors discuss all the key details, including tips for entrants, in our latest podcast.
Teva has laid out an ambitious goal for its long-acting injectable schizophrenia drugs to grow into a $2bn franchise, ahead of the planned US filing of olanzapine later this year.
At a busy meeting of the CHMP, the EMA issued positive opinions for Fresenius Kabi’s denosumab rivals to Prolia and Xgeva, another denosumab biosimilar from Sandoz, a Tecfidera hybrid from Neuraxpharm and a Descovy generic from Viatris. Meanwhile, Ascend has withdrawn a teriparatide filing.
England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.
The International Generic and Biosimilar medicines Association has set out three priority areas that it says should be considered by G7 leaders at the current summit in Alberta, Canada, as part of efforts towards ensuring access to health.
Ahead of a bench trial beginning in February 2026, Lupin has become the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster by the end of the decade.
The US healthcare system saved billions by allowing early market entry for generic and biosimilar medicines through patent settlements. However, long-winded litigations with an expensive price tag and the Senate’s reintroduced pay-for-delay bill are set to make the situation even more dire.
