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Set Alert for Manufacturing

Not In 2023 After All? FDA Turns Down Approval For Coherus’ On-Body Pegfilgrastim

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.”

Biosimilars Value-Added Medicines

US FDA's Cavazzoni Criticizes Plant Shutdown That Triggered Serious Cisplatin Shortage

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.

Manufacturing Generic Drugs

Glenmark Divests API Company, Setting Out On Distinct Journeys

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.”

Commercial M & A

Alvotech Gets A Fresh Date For Adalimumab In US

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.

Biosimilars United States

Beyond Viatris: Kiran Mazumdar-Shaw Talks Next Steps For Biocon Biologics

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.

Biosimilars M & A

Biocon Biologics Moves Quickly To Integrate Viatris In North America

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.”

M & A Biosimilars

Vyvanse Generics Roll Out In US As Suppliers Work To Meet Demand

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.

Generic Drugs Launches

US FDA Warns Intas To Assess Global Quality Following Plant’s Data Integrity Meltdown

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.

Manufacturing Quality

Will Pfizer’s Biosimilars Hit $2bn Again In 2023?

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.

Sales & Earnings Biosimilars

Hikma Hikes Generics Guidance As It Prepares For New CEO

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.

Sales & Earnings Generic Drugs

EDQM Updates Approach To CEPs In Light Of Nitrosamine Regulatory Changes

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.

Drug Safety Manufacturing

Pfizer Rallies To Fix Tornado Damage At Key Injectables Plant

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.

Manufacturing Generic Drugs

Teva Doubles Down On Alvotech Biosimilars Partnership

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.

Deals Biosimilars

‘You Have To Play On A Pretty Broad Part Of The Piano’: Fresenius Kabi On Biosimilar Commitment

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.

Biosimilars Commercial

US FDA Finds Poor Data Integrity At Second Intas Plant

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

Manufacturing Quality

AAM Calls For Congress And FDA To End Shortages By Easing Up On Generics Quality, Pricing

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.

Generic Drugs Supply Chain
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