Generics
Serial patent litigations have become a loophole in the Hatch-Waxman Act, disbalancing the scale of innovation and competition, said Jon Potter, executive director of the newly established Coalition Against Pharma Patent Abuse, in an exclusive Generics Bulletin interview.
More than a dozen semaglutide generics hit the Indian market at sharp discounts post LOE for Novo Nordisk’s GLP-1 RA molecule, setting the stage for a high-octane battle in the diabetes and obesity segment. Can Novo hold steady amid the avalanche and what are KOLs looking for?
After an eventful 2025 that saw the US off-patent industry chalk up wins on tariffs and biosimilar streamlining, AAM president and CEO John Murphy III talks to Generics Bulletin about how the association will be stepping up its lobbying efforts in a US election year.
Natco has announced a 90% difference in the price of its semaglutide generic in multi-dose vials versus originator Novo Nordisk’s Ozempic pen ahead of launch tomorrow, as Novo’s patents on the product expire today. Its pen will be 70% cheaper.
Amid “significant uncertainty” for the off-patent industry caused by the war in Iran, the IGBA has warned that a prolonged conflict “could make solvent supply a critical concern” while escalating costs and squeezed margins could affect the long-term sustainability of affordable medicines.
Zydus’s investment in a differentiated drug-device combination for semaglutide has led to a win-win GLP-1 co-marketing deal with Lupin, even as the Indian drug regulator keeps a watch on advertising activities.
After creating a new biosimilars unit, Sandoz is now divesting its generics portfolio in Sub-Saharan Africa to the Strides Pharma group. Strides will acquire or license these brands for an initial $12m plus royalty, placing it among the top five firms in the region.
Speaking to Generics Bulletin on the sidelines of the AAM’s Access! 2026 conference, IGBA chair for 2026 Jim Keon – also president of the CGPA and Biosimilars Canada – discussed IP abuses, supply challenges, biosimilar streamlining and the importance of giving the off-patent industry a global voice.
As Stada awaits the imminent closure of a deal that will see it come under the ownership of CapVest, the firm has reported 2025 sales that grew by 6% to €4.3bn, boosted by a double-digit biosimilars increase that drove Specialty sales above €1bn for the first time.
A Senate report finds GSK’s withdrawal of Flovent and shift to an authorized generic increased costs, restricted access and disrupted asthma care, while helping the company avoid Medicaid rebates, raising broader concerns over pricing loopholes.
India issues firm advisory on promos for obesity and metabolic disorders therapies ahead of loss of exclusivity for semaglutide later this week, with 50-plus generic brands seen in the wings for a share of the pie. Will Eli Lilly and Novo Nordisk have to tweak their multimedia campaigns?
Merck, Johnson & Johnson, AstraZeneca and Roche are among the big pharma manufacturers that will face substantial exclusivity losses in the US this year.
NRx says the FDA has identified no bioequivalence deficiencies in its Ketafree ANDA, clearing a key hurdle ahead of a potential mid-2026 decision as the firm pursues parallel generic and innovative ketamine strategies.
Polpharma has opened an India office to work more closely with API suppliers, improve oversight and strengthen supply chain resilience, marking an early strategic move under new CEO Sebastian Szymanek.
The final week of February saw the AAM hold its Access! 2026 annual conference in Miami and Medicines for Europe hold its annual regulatory and scientific affairs conference in Amsterdam. Generics Bulletin was there at both events and our reporters discuss the key takeaways in our latest podcast.
The US FDA released one of the highest numbers of product-specific guidances for generic development in a single batch.
Hikma has introduced the first US rival to Nucynta ER in the form of a tapentadol extended-release authorized generic. The launch comes after the firm reported annual sales that were up but profits that were down, with new CEO Said Darwazah promising to right the ship.
Biocon’s FDA approval and Cipla’s US launch – via partner Orbicular – add momentum to the early generic market for Novo Nordisk’s Saxenda.
A proposed settlement would resolve claims that Actelion used REMS restrictions to block generic rivals from accessing Tracleer samples, allegedly delaying competition and inflating prices for insurers and other payors.
Sandoz has unveiled a major reorganization of its generics and biosimilars operations into two distinct businesses, bringing in Ferring and Merck veteran Armin Metzger to lead a new global biosimilars unit while at the same time assigning existing executives to generics roles.