What is a biosimilar?
A biosimilar is a biological medicine that is manufactured to be similar but – unlike a generic pharmaceutical medicine – not necessarily identical to its reference medicine. Such medicines are assessed in terms of their quality, safety and efficacy compared with a reference biological medicine that has already been registered. No clinically significant differences should exist between the safety, efficacy, purity or potency of the reference medicine and the candidate biosimilar. Biosimilars are also known as follow-on biologics or similar biotherapeutic products .
What regulatory guidelines address biologics and biosimilars in South Africa?
Medicines, including biologics and biosimilars, are regulated by:
April 30, 2021 Comments Off on NOTICE TO DISREGARD GSB GOLD STANDARD BANKING CORPORATION AG 262 Views | Short URL
HAMBURG, Germany, April 29, 2021 (GLOBE NEWSWIRE) We are advised by GSB GOLD STANDARD BANKING CORPORATION AG that journalists and other readers should disregard the news release, “GSB Group doubts in gold reserves of Karatbars and the V999 Coin.Read More » April 30, 2021 Comments Off on 1.12 mln people vaccinated in Punjab: Firdous 245 Views | Short URL
Punjab provincial cabinet has decided to increase the number of oxygen beds and ventilators in hospitals across the province on emergency basis.Briefing newsmen in Lahore about decisions taken in cabinet meeting, Special Assistant to Punjab Chief Minis.Read More »
A new collaboration between SNOMED International and ICH promotes seamless data exchange in support of public health | Comunicados | Edición USA efe.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from efe.com Daily Mail and Mail on Sunday newspapers.
London, United Kingdom & Geneva, Switzerland, April 29, 2021and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH) are announcing the release of
A new collaboration between SNOMED International and ICH promotes seamless data exchange in support of public health - News Makers newsmakers.pk - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from newsmakers.pk Daily Mail and Mail on Sunday newspapers.