BioPharmaceutical

China’s National Healthcare Security Administration has responded to reports of complaints from Chinese healthcare professionals about the quality and efficacy of generics purchased through the country’s volume-based procurement scheme.

Samsung Bioepis has reported a major boost to its operating results in 2024, lifted by biosimilar launches that included its Pyzchiva rival to Stelara in Europe through partner Sandoz, which the firm says has gained the largest market share among ustekinumab challengers.

The Teva v. Amneal battle over inhaler patents in the FDA’s Orange Book has become a noteworthy case that will impact both branded and generic drug companies. Yet, the clarity over patent listings might be overshadowed by possible future litigations, discussed law firm Polsinelli’s chair Chad Landmon with Generics Bulletin.

The Chinese company started the new year with a further business agreement after announcing a flurry of biosimilar partnership deals in 2024.

As the generic drug industry warily watches another transition process for propellants in metered-dose inhalers, the US FDA is urging companies not to discontinue development because they are afraid of being caught in the switch.

Almost a year since the establishment of an expanded CDMO business unit, Canada’s Pharmascience has doubled down on its plans to expand its presence through the pharmaceutical industry.

As Sandoz’s north American president Keren Haruvi gears up for a second term as chair of US generics and biosimilars association the AAM, other firms – including Sunshine Biopharma, Centrient and Rosemont – have also announced executive appointments.

The FDA’s CDER has set out a 2025 guidance agenda that promises long-awaited guidance on first interchangeable biosimilar exclusivity, as well as a host of other documents relevant to generic drug development and registration.

Generics Bulletin reviews global regulatory developments from late 2024 and new updates from this year.

CEO Michael Demurjian discusses the importance of reformulated liquid oral suspension drugs, while outlining plans to launch a smart device that connects patients and doctors.