Formycon and MS Pharma have followed up on previous biosimilar collaborations in the MENA region with a fresh alliance on Stelara rival FYB202.
Sawai has teed up multiple new launches in Japan after reporting the listing of five generics across ten presentations in the country’s National Health Insurance drug price list. The new registrations come after the firm reported lukewarm first-half results amid ongoing domestic supply issues.
Indian player Indoco has struck a deal with UK distributor Clarity Pharma that will allow it to target the UK market with the launch of 20 products over the next 18 months.
Chinese biosimilars developer Henlius has celebrated its first shipment to the US, opening up a potentially lucrative market for the firm via local marketing partner Accord.
Coherus is fully exiting the biosimilars space after striking a final deal worth up to $558m to divest its Udenyca US pegfilgrastim franchise to Accord parent company Intas.
The company said the NORSE EIGHT trial of ONS-5010 did not meet the primary endpoint of showing noninferiority to ranibizumab, but it still plans to file for US FDA approval.
Lupin is looking to be ready on day one to challenge Merck & Co’s Janumet (metformin/sitagliptin) treatment for type 2 diabetes, after the US Food and Drug Administration tentatively waved through its ANDA product.
Biocon has become the latest ustekinumab biosimilar developer to garner approval from the US Food and Drug Administration – and the Indian giant already has a settlement in place that will allow it to be among the first to launch in 2025.
Europe risks “missing out on a massive opportunity” if it does not improve its efforts to recognize and take advantage of the benefits of value added medicines, according to Medicines for Europe sector chair and Pharmanovia CEO James Burt.
Viatris is shedding another of its off-patent interests, striking a deal for Safecor Health to acquire its US unit-dose packaging business.
The latest update on product-specific guidances for generic development from the FDA included 60 new and newly-revised PSGs as well as an update on future guidances coming down the line in the next year.
The BGMA has lauded as “comprehensive and welcome” a report published by the Royal Pharmaceutical Society on UK shortages, just weeks after the BGMA put forward its own supply-chain policy proposals.
Mallinckrodt has spoken about maintaining a steady organization, underpinned by few launches in the pain and neurodevelopmental disorders space.
Alvotech will consider its options upon the potential US approval of its proposed biosimilar to Eylea, though the firm maintains that its formulation has been developed with the patent landscape in mind.
Unlike the market-leading Ocrevus, biosimilar competition to Novartis’ Kesimpta blockbuster for multiple sclerosis hasn’t begun to materialize just yet, according to the Swiss originator.
The first GLP-1 agonist to receive US Food and Drug Administration approval, Byetta (exenatide), has generic competition at last, with Amneal bagging the first rival after Teva seemingly abandoned its proposed generic version.
When the agency decided biosimilarity standards would be high, it likely ensured the interchangeability designation eventually would become unnecessary.
With a first wave of generic weight-loss medicines poised to hit the UK, local off-patent industry association the BGMA says market dynamics could be unlike those of a typical generic or biosimilar launch, with the current level of unmet demand unclear.
Regeneron has taken a further swipe at Amgen after the biosimilars sponsor surprised the market by launching the first US rival to Eylea at-risk last month.
MSN Laboratories has struck a patent-litigation settlement deal with BeiGene that will allow it to launch its zanubrutinib generic rival to Brukinsa in the US from 2037.