Generics

Sandoz’s CEO used the firm’s latest results call to highlight “trade distortion” in the pencillins market as a result of US tariffs, urging European authorities to take action to reduce the region’s “geopolitical exposure” and safeguard the long-term sustainability of European-produced penicillins.

Cipla’s global CEO and MD Umang Vohra is moving on handing over the baton to global COO, Achin Gupta. Vohra talks about his innings, where he sees Cipla in 2030 and the impact of the latest FDA action that aims to make biosimilar development faster and less costly.

On its third-quarter earnings call, Biogen’s management said the company remains well positioned despite accelerating generic pressure in Europe and the imminent US launch of Sandoz’s Tyruko biosimilar.

Dr Reddy's had not ruled out "queries" from the Canadian regulator for generic semaglutide, though it is confident of selling “all its capacity” for the GLP-1 across target markets. A backup CMO site in the US for abatacept is expected to mitigate risks amid tariff and other uncertainties.

A pair of Form 483 reports detail numerous observations of GMP violations at Hetero Labs’ facilities, exposing systemic quality and documentation failures, including the presence of lizards, birds, and cats.

Companies have been given two extra weeks to decide whether they want to leave the UK’s voluntary pricing scheme for branded medicines, adding to a previous four-week deadline extension.

Sandoz triumphed across four categories in the Global Generics & Biosimilars Awards 2025, with other winners including Accord, Adalvo, Amneal, Aurobindo, Cencora, Centrient, CNX Therapeutics, Hikma and Samsung Bioepis, as well as the AAM and its Biosimilars Council.

The introductory meeting did not suggest changes to the expected schedule and operations for renewing the generic drug user fee, said AAM’s Giuseppe Randazzo.

Beximco said it will manufacture a generic rival to Vertex’s Trikafta, offering cystic fibrosis patients a much-needed cheaper alternative. However, people will be subject to domestic personal use importation laws to access the drug.

With the work undertaken by non-governmental organization International Health Partners to provide access to vital medicines more important than ever, the organization talks to Generics Bulletin about how its work is growing and how companies in the off-patent sector can get involved.

The AAM has asked for a federal injunction to block a Connecticut state law on drug pricing that it says represents “an unconstitutional overreach that threatens patient access to affordable medicines.”

Sawai’s settlement brings an end to a years-long legal battle over the manufacturing method for the firm’s generic teriparatide injection, following a court ruling that upheld Asahi Kasei’s process patent for its osteoporosis brand Teribone.

The EU’s top court has rejected Teva and Cephalon’s final appeal, ruling that their 2005 settlement to delay a generic version of modafinil was inherently anticompetitive and upheld a €60.5m fine.

PharmaTher will use the power of artificial intelligence to propel the development of ketamine-based therapies.

Strides and Incepta’s partnership on the first generic injectable contraceptive marks a leap forward for many women in Africa to take control of their reproductive rights.

US firm’s first-to-market approval gives Endo a foothold in the rare metabolic disease space, widening access to a life-saving therapy for patients with urea cycle disorders.

The Supreme Court of India has allowed Natco Pharma to continue selling its generic version of Roche’s spinal muscular atrophy drug Evrysdi (risdiplam), declining to interfere with a Delhi High Court order that denied Roche an injunction while the patent infringement case proceeds.

Aspire Pharma is expanding again, with the acquisition of fellow UK firm and niche generics developer Charlwood Pharma.

As the European Commission prepares to publish its latest study on the Urban Waste Water Treatment Directive, industry leaders have bemoaned a lack of consultation and have suggested that a simple update of existing cost estimates should be replaced by a more thorough impact assessment.

While branded generics and biosimilars remain subject to the UK’s VPAG pricing scheme, Sandoz’s public affairs lead has argued that focusing on driving competition and uptake rather than rebates is a better way to generate savings – and that off-patent products should be exempt from VPAG altogether.