More Articles

How local policy measures and practices influence originator biological and biosimilar market dynamics in Sweden Biosimilars/Research | Posted 21/06/2019

The licensing of biologicals, including biosimilars, in Europe is centralized via the European Medicines Agency (EMA). Subsequently, individual European Member States are responsible for pricing, r...

FDA approves trastuzumab biosimilar Kanjinti Biosimilars/News | Posted 21/06/2019

US-based pharma giant Amgen and Netherlands-based Allergan announced on 13 June 2019 that it had received approval from the US Food and Drug Administration (FDA) for its trastuzumab biosimilar Kanj...

Recommendations for similar biotherapeutic products published by Latin American MS experts Biosimilars/General | Posted 21/06/2019

Recommendations for the use of similar biotherapeutic products for multiple sclerosis (MS) have been issued by a group of experts from Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuad...

Alteogen gains approval to start aflibercept biosimilar trial in Korea Biosimilars/News | Posted 21/06/2019

South Korean biologicals company Alteogen announced on 22 May 2019 that it had gained approval from the Korean Ministry of Food and Drug Safety (MFDS) to initiate a clinical trial for its afliberce...

Canada’s British Columbia to switch patients to biosimilars Policies & Legislation | Posted 21/06/2019

British Columbia has become the first Canadian province to stop coverage of originator biologicals and switch patients to biosimilars for certain indications.

Positive phase I results for Bio-Thera’s bevacizumab copy biological Biosimilars/Research | Posted 21/06/2019

China-based Bio‑Thera Solutions (Bio‑Thera) has published phase I results for its candidate bevacizumab copy biological, BAT1706 [1].

Boehringer Ingelheim finally signs licensing deal for Humira biosimilar Pharma News | Posted 21/06/2019

Boehringer Ingelheim (Boehringer) has finally given in and signed a licensing deal for its Humira biosimilar, Cyltezo (adalimumab), in the US.

FDA approval for Unichem Lab’s hydrochloride medicines and Teva’s nasal spray to treat opioid overdose Generics/News | Posted 21/06/2019

The US Food and Drug Administration (FDA) has granted Unichem Laboratories a tentative abbreviated new drug approval (ANDA) for their generic hydrochloride tablets, and has approved the first gener...