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
The FDA’s CDER has set out a 2025 guidance agenda that promises long-awaited guidance on first interchangeable biosimilar exclusivity, as well as a host of other documents relevant to generic drug development and registration.
In the aftermath of last week’s J.P. Morgan Healthcare Conference in San Francisco, Generics Bulletin’s editorial team brings you additional coverage of items of interest for the global generics and biosimilars industry.
New US president Donald Trump’s pick for HHS secretary, Robert F. Kennedy Jr, has been sent a slew of questions by senator Elizabeth Warren that touch on a number of areas of relevance for generics.
Responding to the announcement by the US Centers for Medicare & Medicaid Services of the 15 additional drugs that will soon be subject to price negotiation – including Ozempic, Rybelsus and Wegovy – the Association for Accessible Medicines has called out the “short-sighted government price setting scheme” for undermining generic and biosimilar competition.
Recently-appointed president of Medicines for Europe Stephan Eder speaks to Generics Bulletin about the off-patent association’s priorities to secure a sustainable operating environment for the generics, biosimilars and value-added medicines sector in Europe.
At the J.P. Morgan Healthcare Conference in San Francisco, Sandoz CEO Richard Saynor commented on the “offensively” low pricing for antibiotics in the US – “less than a packet of M&Ms” – while also revealing that the firm has struck a deal with a US PBM for its Samsung Bioepis-partnered Pyzchiva ustekinumab biosimilar to Stelara.