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TGA proposes changes to biologicals regulations Guidelines | Posted 18/05/2018

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA) announced on 20 April 2018 the release of proposed amendments to its biologicals regulations that are set to take effe...

Brazilian oncologists favour ‘follow-on biological products’ Biosimilars/Research | Posted 18/05/2018

The Brazilian Society of Clinical Oncology (SBOC) has issued a position statement on ‘follow-on biological products’ in oncology. The statement reflects the society’s views on issues such as naming...

Sanofi to sell Zentiva generics arm to Advent Pharma News | Posted 18/05/2018

French drugmaker Sanofi announced on 17 April 2018 that it had entered into exclusive negotiations with Advent International (Advent) under which Advent would acquire Zentiva, Sanofi’s European gen...

Biosimilars substitution bill becomes law in South Dakota Policies & Legislation | Posted 18/05/2018

The latest state to enact a law that allows the substitution of biosimilars at the pharmacy level is South Dakota. The signing of the bill marks the first biologicals substitution bill in 2018 to b...

Hikma launches HIV generic ritonavir in the US Generics/News | Posted 18/05/2018

Jordan-based drugmaker Hikma Pharmaceuticals (Hikma) announced on 20 March 2018 that its wholly owned US subsidiary West-Ward Pharmaceuticals Corp had launched generic ritonavir tablets (100 m...

Secrecy is an obstacle to the use of biosimilars in the US Biosimilars/Research | Posted 11/05/2018

Factors that Professor Frank believes may be affecting uptake include naming and interchangeability guidance, insurance payment arrangements and secrecy about manufacturing processes [1]. In this a...

Biosimilar etanercept Eucept approved in South Korea Biosimilars/News | Posted 11/05/2018

South Korea-based LG Chem has obtained regulatory approval to begin marketing and selling its etanercept biosimilar in Korea.

Safety of biosimilar infliximab in pregnant women with IBD Biosimilars/Research | Posted 11/05/2018

Introduction of the first biosimilar infliximab (CT‑P13, Remsima/Inflectra) for the treatment of inflammatory bowel diseases (IBDs) was aimed to reduce the healthcare cost burden and to increase th...