Manufacturing

Coherus BioSciences says that it will work closely with the US Food and Drug Administration and the unnamed third-party filler to obtain approval for its proposed version of Neulasta Onpro on-body injector “as quickly as possible.”

Director of the FDA’s center for drugs slams firm for failing to reach out before suspending operations in the wake of an inspection that raised serious data integrity concerns. Instead, firms should be alerting the agency as soon as they realize there could be shortages.

Glenmark Pharmaceuticals has divested its API arm to the Nirma group for over $681m, a move that will deleverage the drug maker’s balance sheet as it seeks to evolve into an “innovative/brand led organization.”

Alvotech has revealed a US FDA goal date of 24 February 2024 for its refiled AVT02 proposed high-concentration interchangeable adalimumab biosimilar rival to Humira, as the firm provided further details of the resubmission – including an expected facility reinspection.

As Biocon Biologics completes its integration of the biosimilars front-end business that it acquired from former partner Viatris, Biocon founder and chairperson Kiran Mazumdar-Shaw talks to Generics Bulletin about how the firm is now capturing the full value of its biosimilars, while also looking at expanding into new markets previously unserved by Viatris.

Biocon Biologics has announced the latest milestone in its integration of former partner Viatris’s biosimilars business, completing the move in the US and Canada “ahead of schedule.”

Hot on the heels of multiple US FDA approvals for rivals to the blockbuster ADHD brand Vyvanse, generics suppliers have confirmed launches – and with drugs in this category currently facing shortages, developers are eyeing significant demand.

Warning letter details extensive GMP and data integrity remediation expectations for Matoda plant and calls for the privately held generic drug manufacturer to immediately confront its corporate quality issues globally.

While Pfizer has for a couple of years now brought in annual global biosimilars turnover of more than $2bn, half-year sales suggest this may not be a sure thing in 2023 – although the firm’s strategy on adalimumab in the US could play a decisive role.

After a tough 2022 for its generics business, Hikma is predicting big things for the division this year, raising its full-year guidance from 20% growth to nearly 30% as new CEO Riad Mishlawi prepares to take the reins from the start of September. Meanwhile, the firm has also picked up assets from Akorn following its collapse.

The European Directorate for the Quality of Medicines & HealthCare has issued updates on “certificates of suitability” for manufacturers in light of new regulatory developments on addressing nitrosamine impurities in drugs.

In the aftermath of tornado damage to Pfizer’s US Rocky Mount sterile injectables plant, the company has set out relief efforts while acknowledging the “critical role” the facility plays for the US healthcare system.

Teva will get more involved in Alvotech’s quality oversight as part of enhancements to the pair’s US biosimilars collaboration that will also see two products added to the deal, as well as a $40m investment in Alvotech from the Israeli giant.

During a broad and wide-ranging interview, taking place in the aftermath of Fresenius Kabi’s entry into the US adalimumab biosimilar market, president of the firm’s Biopharma business, Michael Schönhofen, talks about Kabi’s ambitions in the space, and how it is positioned to be a long-term player.

After machines counted particles in vials, workers revised reports so out-of-specification batches could be exported to the US and the EU.

Remote inspection alternatives could allow quicker resolution of quality issues that are holding up US imports, says association for generic drug manufacturers. AAM adds that adjusting a Medicaid inflation penalty could relieve unfair price pressures.