As Biocon Biologics picks up the latest approvals in Europe for its Stelara biosimilar, Blake Leitch, the firm’s head of Europe, talks to Generics Bulletin about what lies ahead for Biocon and for biosimilars more widely in the region – including tackling the “biosimilar void”.
At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.
The FDA has concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements, and that there was no “mistake” or untrue statement in the original ANDA approvals, as it denied Vanda’s citizen petition.
Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.
Clinical-stage reformulation specialist Lipella Pharmaceuticals has insisted that “our commitment to our shareholders, our mission, and our clinical goals has not changed” after its common stock was delisted from the Nasdaq Capital Market.
Viatris has secured two positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use for generics to two blockbusters: Gilead’s HIV drug Odefsey and Boehringer’s IPF treatment Ofev, with a path to approvals possible in 67 days.
The AAM has welcomed a US appeals court decision backing an injunction against a Minnesota state law on drug pricing, following an earlier favorable district court ruling.
As Medicines for Europe gears up for a pair of conferences in Brussels next week, the organization has set out trade policy recommendations to strengthen access to medicines and the competitiveness of EU manufacturing, in a seminar with representatives from the European Commission and member states.
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.
With the August 1 deadline looming for entries to the Global Generics & Biosimilars Awards 2025, contenders have just one month left to submit their achievements.
Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.
Clinical-stage reformulation specialist Lipella Pharmaceuticals has insisted that “our commitment to our shareholders, our mission, and our clinical goals has not changed” after its common stock was delisted from the Nasdaq Capital Market.
At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.
The US Federal Circuit’s March 2025 decision affirming a lower court’s determination on both induced infringement and non-obviousness concerning a key patent shielding Janssen’s Invega Trinza (paliperidone palmitate) long-acting injectable is set to stand – for now.
Among other schemes, Cigna alleges that Celgene and parent Bristol Myers Squibb “paid” generic challengers – via lucrative Revlimid profit-sharing agreements – to delay generic market entry for Pomalyst until 2026, unlawfully extending their monopoly and overcharging purchasers.
The US Supreme Court is seeking a brief “expressing the views of the United States,” following the US Federal Circuit’s decision to reopen Amarin’s claim of induced infringement against Hikma relating to its ‘skinny-label’ generic Vascepa (icosapent ethyl) product.
