market.usThe EMA has asked the industry to share their thoughts on its draft guidelines for developing and assessing biosimilars. The idea is to make it easier for patients in the EU to get access to biosimilars, while also keeping Europe a good choice for developers.
Tag Archive for: Biosimilars
AVT03, a biosimilar candidate for osteoporosis treatment, showed promise in treating bone illnesses, according to results from a pharmacokinetic study by Alvotech SA.
Generic and biosimilar manufacturer Sandoz is expanding with a new biologics production facility in Lendava, Slovenia to prepare for more demand in Europe for biosimilar products.
The region regulated by the European Medicines Agency (EMA) has been the most proactive globally in the early adoption of biosimilars. By February 2023, it had approved around 75 products containing them. The distribution of such compounds within Europe, however, has been uneven, with some countries offering more market opportunities than others. Beyond Europe, few producers have a strategy for the Middle East and/or Africa, and India and South Korea could soon jump in to fill the gap.