Lupin has shown its confidence in its legal position after introducing the first US generic version of Galderma’s rosacea treatment, Oracea, while the originator battles for injunctive relief.
Lupin has pressed ahead with launching the first generic version of Galderma’s Oracea (doxycycline) modified-release capsule treatment for rosacea in the US, weeks after a US district court markedly found in the Indian’s firm favor in patent-infringement litigation.
The generics manufacturer’s launch comes ‘at risk’, with litigation ongoing
Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.
As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.
With a lineup of five high-value biosimilars in the wings, Biocon Biologics may be more selective going forward and plans to take a one product per year approach.
As financial volatility continues in the industry, Biocon’s board is considering merging its two off-patent drug businesses.
As financial volatility continues in the industry, Biocon’s board is considering merging its two off-patent drug businesses.
Eight more ANDA filers remain in play challenging patents shielding Esperion’s Nexletol (bempedoic acid) after Micro Labs deal out litigation via a settlement agreement.
Viatris continues to make progress on remediation at the firm’s stricken manufacturing facility in Indore, India, following a warning letter and import alert delivered at the tail end of 2024.
