Generics

The FDA wants to waive facility fees for three years if a sponsor breaks ground on a US-based manufacturing plant, but industry is concerned the idea will force other sponsors to subsidize competition.

After taking the reins as president of Medicines for Europe at the start of 2026, Zentiva CEO Steffen Saltofte sets out priorities for the group that include ensuring access to medicines, industry resilience and competitiveness, harmonized regulation, and sustainability for the off-patent sector.

Strides Pharma aims for higher revenues from Canada and other ex-US markets while waiting for controlled substances to ramp up gradually under the leadership of ex-Apotex CEO Peter Hardwick. However, a cut in US funding for the Global Fund is hurting the company and its competitors.

With another settlement secured, US states are gearing up for the first trial of the price-fixing case later this year.

Sun’s founder reinforces the firm’s M&A strategy, indicating that it is "comfortable raising debt" if required, but shares no specific comment on the speculated interest in Organon. The Indian company also has "sufficient supplies" to meet demand for generic semaglutide in India post LoE.

The US Supreme Court’s decision to review Hikma and Amarin’s litigation over induced infringement of carved-out patented indications offers a chance to resolve key questions around skinny-label generics, according to Chad Landmon, chair of law firm Polsinelli’s Hatch-Waxman & biologics practice.

BC Partners has completed its acquisition from Servier of French generics giant Biogaran after the French government allowed the private-equity takeover on condition that BPI France take a minority stake. Meanwhile, former Biogaran CEO Erick Roche has returned to the role after a long stint at Teva.

Transpire Bio continues to advance its complex generics franchise, with another Paragraph IV filing for GSK’s Ellipta portfolio inhaler.

The US Association for Accessible Medicines has named Lupin’s Bob Hoffman as its new chair. Meanwhile, departures have been seen at Stada and Dr Reddy’s, among other industry management changes.

A US class action suit alleges that a settlement between Teva and Novo Nordisk illegally delayed generic Victoza for 16 months, kept prices high and transferred an estimated $903m in value to Teva.

Dr Reddy’s gears for semaglutide debut across markets, including India and Canada, where Novo Nordisk has second brands of the GLP-1 agonist potentially ready. Can the Indian group close out compliance queries from the Canadian regulator soon?

Sun Pharma’s generic Wegovy product has cleared regulatory review, positioning the company to enter India’s obesity drug market once patent protection lapses.

In line with previously disclosed launch and partnering plans for GLP-1 products, Lupin shook hands with Galenicum, securing commercial rights to injectable semaglutide.

Generics Bulletin reviews global regulatory developments across the world.

Amarin has hit back over the US Supreme Court’s decision to review skinny-label induced infringement litigation with Hikma over Vascepa (icosapent ethyl).

Biocon Biologics has become one of the most prominent global biosimilars firms since its buyout of former partner Viatris’ biosimilars business. With a rumored IPO instead making way for a merger with generics unit Biocon Ltd, the business’s chief Shreehas Tambe sets out the reasons for the move.

Following a rebrand in 2024 with a mission to expand to global markets, Latvia’s Olpha has started shipping cholesterol management drugs to Mexico after winning a government supply tender.

With needed funds in its pocket, Biocon is prepared to simplify and integrate its growing off-patent medicines portfolio under one roof.

Marking the latest step in the long-running saga of Hikma and Amarin’s induced infringement dispute over Vascepa (icosapent ethyl), the US Supreme Court has agreed to review the litigation, which cuts to the heart of key issues around skinny-label generics and carved-out indications.

European CNS specialist rolls out a value-added methylphenidate and a first-to-market guanfacine generic as it sharpens its European ADHD strategy.