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 David Wallace
Responding to questions seeking clarifications over a statement on the scientific rationale supporting the interchangeability of biosimilars in the EU, the EMA has issued a supplementary Q&A document to address issues around multiple switches, complexity of molecular structure and national switching policies.
Shanghai Henlius Biotech has announced the start of Phase I trials for its HLX15 proposed daratumumab biosimilar rival to Darzalex. But the Chinese firm is not the only developer chasing the $8bn brand.
Sandoz is set for a “trough year” in 2023 as the generics and biosimilars unit faces costs linked with its spinoff from parent company Novartis that will erode its core operating income.
Amgen’s biosimilars sales are on the decline, largely due to erosion of its oncology portfolio. However, the debut of first US Humira rival Amjevita, along with planned versions of Stelara and Eylea, are expected to push the segment back into growth.
Fresenius Kabi and Formycon have announced a global licensing deal for the FYB202 ustekinumab proposed biosimilar rival to Stelara. The deal comes as Formycon has revealed plans to raise further funds to funnel into research and development through a fresh share issue.
The launch of Amgen’s Amjevita, the first US biosimilar rival to Humira, has been accompanied by multiple fresh forecasts of how competition could play out this year, with a host of further biosimilar launches on the horizon.