Generics Bulletin Executive Editor Dave Wallace has more than 10 years' experience of reporting on the global generics, biosimilars and value-added medicines industries. Having begun his career in the European chemicals industry, Dave has now spent over a decade with Generics Bulletin, becoming editor from 2018. 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 acts as a judge for the annual Global Generics & Biosimilars Award.
Latest From David Wallace
Hikma has pushed back against a further attempt by Amarin to counter its US generic version of Vascepa, this time via a fresh lawsuit claiming that the generic induces infringement of patents protecting cardiovascular indications for which the brand is approved but which are carved out of the generic label.
Sandoz has launched an awareness campaign under the banner of “Ask For Generics” in the US. The initiative is aiming to educate stakeholders on the benefits of generics and their quality, safety and efficacy.
Development Partners International, CDC Group and the European Bank for Reconstruction and Development have collaborated to create a “first of its kind, pan-African” generics platform built on the acquisition and combination of Egypt’s Adwia Pharmaceuticals and India’s Celon Laboratories. An initial $250m investment is to be followed by up to $500m in further funding.
Shanghai Henlius Biotech has begun dosing in a Phase I trial for its HLX14 planned biosimilar version of denosumab. Multiple biosimilar developers are vying to take a slice of the market for rivals to Amgen’s Xgeva/Prolia original.
China’s Bio-Thera Solutions has ventured outside of its domestic market for the first time by filing an application for a biosimilar version of Avastin with the European Medicines Agency. The company has also revealed its timeline for a submission to the FDA.
The European Commission’s newly-published Pharmaceutical Strategy features a range of proposals related to generics and biosimilars, including “targeted policies” to improve competition, remove barriers and increase uptake.