Tracing its roots back to Basel in the late nineteenth century, Sandoz has confirmed the location of its new planned permanent headquarters post-spin.

Lupin has collaborated with Alkem subsidiary Enzene Biosciences to launch the first ever cetuximab biosimilar in India. 

Coherus BioSciences had teased a “compelling value proposition” for its Yusimry (adalimumab-aqvh) biosimilar to AbbVie’s Humira blockbuster and it has delivered, with a pair of pricing strategies include one though an alliance with self-labelled “disruptor” Mark Cuban.

Biocon is confident of its “four channel strategy” for the upcoming debut of biosimilar Humira in the US and also asserts it’s well positioned to compete when price cuts come into play for Sanofi’s Lantus next year.

Amphastar has delivered another successful quarter, bolstered by sales of glucagon and epinephrine, as it prepares to roll out a number of commercially attractive products and complete a significant branded product acquisition.

Having recently added to its biosimilars alliance with Alvotech, Dubai-based Bioventure says it is looking to expand its international reach through further partnerships.

Making the Office of Therapeutic Biologics and Biosimilars a stand-alone office in CDER may allow it to add more expertise, but is there an appetite for another reorganization?

New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific guidances to harmonize standards.

Ahead of its annual meeting in Malta in mid-June, European off-patent industry association Medicines for Europe has set out the hot topics for generics and biosimilars stakeholders that delegates will be looking to discuss.

An agency official said the GDUFA III provision hopefully will be used for only a small number of ANDAs. We chart the approval times and first-cycle clearances over the course of the generic user fee program.

A fresh report has offered stark new data on the extent to which generics are disappearing from the European market. Industry association Medicines for Europe has pointed to the risks of supply consolidation, urging both national- and EU-level action.

As the WHO seeks input on a global accord to strengthen pandemic preparedness, the IGBA has provided suggestions from the off-patent industry ahead of a key step in the drafting process later this month.

Generics Bulletin previews the most notable and anticipated events for June 2023.

Amphastar has delivered another successful quarter, bolstered by sales of glucagon and epinephrine, as it prepares to roll out a number of commercially attractive products and complete a significant branded product acquisition.

Having recently added to its biosimilars alliance with Alvotech, Dubai-based Bioventure says it is looking to expand its international reach through further partnerships.

Lupin has collaborated with Alkem subsidiary Enzene Biosciences to launch the first ever cetuximab biosimilar in India. 

Coherus BioSciences had teased a “compelling value proposition” for its Yusimry (adalimumab-aqvh) biosimilar to AbbVie’s Humira blockbuster and it has delivered, with a pair of pricing strategies include one though an alliance with self-labelled “disruptor” Mark Cuban.

Generics Bulletin previews the most notable and anticipated events for June 2023.

Generics Bulletin previews the most notable and anticipated events for June 2023.

Coherus BioSciences spoke at length about its two marketed biosimilars, referencing Neulasta and Lucentis, during the company’s first-quarter earnings call.

Teva has indicated an imminent launch after gaining a long-awaited FDA approval for the Uzedy long-acting injectable risperidone 505(b)(2) hybrid product on which the firm has partnered with MedinCell. Pricing information has also been revealed.