Medicines for EuropeIn a surprise move, Health Commissioner Oliver Várhelyi announced at the Medicines for Europe Annual Conference that the EU Biotech Act will go ahead this year, reversing its provious delay from Q3 2025 to Q3 2026. The legislation has now been fast-tracked because the Commission recognised biotechnology’s rising geostrategic weight.
Tag Archive for: Regulatory
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.