Having previously worked in the European chemicals industry, Dave has been with Generics Bulletin since 2010. Keeping a close eye on deals, corporate strategy and market developments in the off-patent sector, he also brings his background and education in law to bear on industry litigation as well as national legislative and regulatory affairs, with a particular interest in France where he has lived and studied in the past. A regular delegate to generics and biosimilars events and conferences as well as a frequent panel moderator, he maintains close links with industry representatives around the world. He also organizes and judges the annual Global Generics & Biosimilars Awards. In his spare time, he enjoys art and playing the piano.
Latest from Dave Wallace
Sandoz passed a major milestone in 2024, with the firm’s sales for the first time exceeding $10bn on the back of a significant rise in biosimilars turnover. The company is continuing to push ahead with restructuring initiatives and also addressed the potential threat of US tariffs as management discussed the firm’s annual results.
In a wide-ranging conversation, the AAM’s president and CEO John Murphy talks to Generics Bulletin about how the US industry association is planning to gain traction with the new Trump administration by adopting “a much more aggressive communications approach” on topics including medicines shortages, trade tariffs, PBM reform, the IRA and biosimilar interchangeability.
Amgen has confirmed to Generics Bulletin details of its launch of Bkemv, the first US biosimilar to Soliris.
Two recent disclosures from Xbrane Biopharma and Formycon demonstrate the evolving US Food and Drug Administration thinking about the need for Phase III trials to support biosimilar filings.
Celltrion has become the third firm to win FDA approval for US biosimilar rivals to Prolia and Xgeva. But with multiple denosumab competitors set to launch in just a couple of months, and several more candidates on the way, the market looks likely to be another competitive one for biosimilar sponsors.
Fresenius has become the latest firm to launch a Stelara biosimilar in both the US and Europe, bringing partner Formycon’s Otulfi version to market. But with heavy discounting already seen in the US and multiple competitors already established in the EU, will the firm be able to stand out from the crowd?