Generics Bulletin Managing Editor Dave Wallace has nearly 10 years experience of reporting on the global generic, biosimilar, value-added and OTC medicines industries. Bringing his background and education in law to bear on industry litigation - as well as national legislative and regulatory affairs - he also keeps a close eye on corporate strategy, personnel moves, and product pipelines. A regular delegate to industry events and conferences, he has a particular interest in local market developments, maintaining close links with national industry representatives. He also organizes and judges the annual Global Generics & Biosimilars Awards. A French speaker, Dave enjoys music - with a love of the piano - and visual arts.
Latest From David Wallace
Following Perrigo’s announcement of a recall of its generic albuterol inhalers in the US, the FDA has commented on the move and has revealed that thousands of complaints have been received over the clogging problem.
Hikma has received another setback on its US application for a generic version of Advair following a minor complete response letter from the FDA. The resulting delay will push back the expected final response date from the agency closer to that expected by rival Cipla, which filed an ANDA earlier this year.
Accord Healthcare has garnered the first positive opinion recommending granting a pan-European marketing authorization for a generic version of rivaroxaban from the EMA’s CHMP. However, originator Bayer claims that no generic competition will be possible for another three years.
After a high-profile launch early this year, first-mover Perrigo has recalled its albuterol sulfate aerosol in the US following complaints of inhalers failing to dispense due to “clogging.” The firm has revealed the expected financial impact of the move as well as commenting on how long it expects the product to be off the market, during which albuterol rivals Cipla and Lupin could benefit.
Pfizer has received an endorsement for a pan-European marketing authorization for its Nyvepria pegfilgrastim biosimilar from the EMA’s CHMP. However, the company would not be drawn on commercialization plans amid competition from numerous other approved versions.
Fresenius Kabi must pay Eli Lilly €28m in damages after a French court of first instance found that the generics firm’s pemetrexed infringed intellectual property protecting the Alimta chemotherapy brand. The German firm has commented on possible next steps.