Reformulation specialist Lipella has an eye on numerous milestones for its proposed oral rinse liposomal formulation of tacrolimus, including the submission of a Phase IIb clinical trial investigational new drug application.
Alvotech has followed its European filing for a biosimilar to Regeneron’s Eylea (aflibercept) 2mg with acceptance for review from the US Food and Drug Administration for its AVT06 candidate.
In an update to its strategy for dealing with US tariffs, Korea’s Celltrion has revealed actions taken so far, as well as outlining plans to consider moving “swiftly” to secure US manufacturing for APIs if circumstances demand.
While quarterly revenues show ups and downs in each region, Lupin is set on continued growth, with a touch of complexity and innovation – including shifting its thinking on the attractiveness of biosimilars.
A journey began eight years ago continues for Doc Generici – now rebranded as DOC Pharma – as it continues to diversify its offerings beyond conventional generic prescription pharmaceuticals.
Cosette Pharmaceuticals has made two key executive appointments as it looks to build up its business. Meanwhile, Canada’s CGPA has named a chair and vice-chair, and Chanelle and Neuraxpharm have announced their own executive changes.
Unleashing a trio of major announcements, Formycon has indicated a gloomy outlook for US Stelara biosimilar pricing; revealed plans to pause commercialization of its Sandoz-partnered US Cimerli rival to Lucentis amid discounting from rivals; and set out ambitious plans to win FDA approval for its proposed Keytruda biosimilar without any Phase III data.
Samsung Bioepis is only the second firm to receive a US FDA endorsement for its denosumab biosimilars, with the nod coming at the same time as formal European Commission approval. But plenty more firms are waiting in line with their own rivals to Prolia and Xgeva.
Sanofi has bolstered its insulin offerings by bagging the first US FDA approval for a rapid-acting insulin aspart biosimilar, leaving several would-be sponsors in its wake.
While biosimilars updates were thin on the ground as Biogen reported its full-year results, the segment nevertheless reported growth in 2024. Meanwhile, the firm also offered some comments on how it saw generic and biosimilar competition to its Tecfidera and Tysabri multiple sclerosis brands playing out this year.
Having secured approvals for the Eylea biosimilar in major markets such as the US and Europe, Formycon has signed a fresh licensing deal with Lotus Pharmaceutical, giving away rights to the asset in the APAC region.
A US tariff on imports from China raises the spectre of similar action against India, but Aurobindo, the largest generics company in the US by prescriptions dispensed, assures it has alternatives in place. While trials for an opthalmology biosimilar are delayed, supply of other biosimilars to Europe is set to begin in Q2 FY26.
Zydus’ latest results faced scrutiny from industry analysts due to a mixed performance where weaker revenue in the Indian company’s domestic market was offset by growth in the US. Meanwhile, the firm has just agreed a deal with Synthon for a 505(b)(2) hybrid product in the US.
Momentum is building around the European Commission’s race to propose a Critical Medicines Act, which aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU.
Canada’s largest generics manufacturer Apotex will look to expand its channels to include health food stores, new professional channels including naturopathic doctors, and grocery retail channels, after acquiring Ontario-based natural health firm CanPrev for an undisclosed sum.
Biocon Biologics’ management shared updates regarding their facilities, expansion, and fast upcoming ustekinumab biosimilar launch in the US. Also, Biocon made a final acquisition payment to Viatris, while increasing its stake in the biosimilars business.
Having recently acquired Coherus’ biosimilar pegfilgrastim franchise in the US and welcomed FDA approval for its partnered ustekinumab biosimilar, Accord Biopharma is again spending big to flesh out its US biosimilar pipeline.
India’s Gland Pharma had much to discuss during its financial third-quarter earnings call, including a recent CDMO partnership with China’s Shanghai Henlius Biotech that could lead to the establishment of further manufacturing space to meet demand.
Bio-Thera Solutions has taken the next step towards launching competition to Johnson & Johnon’s Simponi blockbuster, filing its Stada-partnered BAT2506 golimumab candidate with Europe’s regulatory body following successful Phase III comparison data.
Speaking during its financial Q3 earnings call, Sun Pharma’s management has again pooh-poohed any idea of jumping into biosimilars in the near future, while providing updates on its trio of stricken Indian manufacturing facilities.