Manufacturing
During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.
When it comes to predicting the future for generic GLP-1s, Sandoz CEO Richard Saynor believes that “everyone’s asking the wrong questions,” pointing to the importance of manufacturing capacity and ability to supply the, rather than the potential market size, as the key factor.
Axplora made waves with a recent announcement that the API specialist’s total investments for 2025 would exceed €100m. Anant Barbadikar, co-president of the firm’s PharmaZell business unit, explains how the firm’s strategy is evolving and why he believes the future of pharma remains small-molecule.
Xbrane Biopharma has unlocked some much-needed cash after passing the milestone of kicking off a trial for its Intas-partnered Xdivane (nivolumab) biosimilar rival to Opdivo.
UK ruling clears the way for Alvotech to stockpile its aflibercept biosimilar ahead of Eylea’s SPC expiry later this month, positioning the firm for a day-one launch across Europe and the UK.
Capital tightening and shifting US regulations slowed contract manufacturing orders in Q3, though Richter sees normalization ahead as new European clients come online.
Viatris says initial corrective work at its oral solid dose site in India is “substantially complete” and that it has met with the FDA to discuss next steps following last year’s warning letter and import alert.
The US FDA had good news and bad news for Alvotech as it issued a complete response letter for its Teva-partnered golimumab biosimilar. While manufacturing deficiencies must be resolved before the Simponi rival can be approved, the FDA “did not identify any other deficiencies with the application.”
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.
In a detailed interview, Aurobindo’s European CEO Venugopalan Muralidharan – Murali – explains how the firm is increasingly focusing on complex products such as injectables and biosimilars, as well as eyeing upcoming opportunities such as GLP-1s and ADCs, while also remaining open to potential M&A.
Lupin has become the latest company to announce plans to build a manufacturing facility in the US, as confusion over tariffs and incentives to pursue “Made in America” drugs persists.
The latest incentive for firms to localize production in the US will see the FDA launch a pilot program to prioritize the review of US-manufactured and tested ANDA products.
Generics Bulletin editor Dave Wallace talks to John Murphy III, president and CEO of the US Association for Accessible Medicines, about the association’s latest annual savings report and key topics affecting the US off-patent market.
In a strongly-worded broadside against those who would seek to water down the EU’s Critical Medicines Act, Medicines for Europe has criticized the “selfishness” of certain actors in pursuit of lower prices at the cost of supply security.
Celltrion has paid out an initial $330m to acquire a US biologics manufacturing facility from Eli Lilly that it says will offer a “fundamental elimination of US tariff risks,” with the Korean biosimilars giant setting out plans to invest around a billion dollars in the plant overall.
Sandoz has lent its backing to a communiqué adopted at the European Forum Alpbach that aims to safeguard and strengthen EU-based antibiotic production.
The European Parliament has suggested clear rules on the proportion of medicinal product manufacturing that must take place in the EU, EEA, or Switzerland for drugmakers to be favored under the Critical Medicines Act, which aims to drive investment in Europe.
Adcock Ingram celebrated a minor turnaround in the back half of its 2025 financial year, though its Prescription division trading profit still fell well short of last year’s level.
Launching its new manufacturing site in New Jersey will help bring Biocon Limited closer to the US market while also bolstering vertical integration, explains the firm’s managing director and CEO Siddharth Mittal in an exclusive interview about the new development.