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Stakeholder perspectives on biosimilars in oncology Biosimilars/Research | Posted 05/10/2018

Monoclonal antibody biosimilars represent a novel advance in the field of oncology, and their integration into routine clinical practice present challenges for clinicians, nurses, patients and regu...

EC approval for adalimumab and pegfilgrastim biosimilars Hulio and Udenyca Biosimilars/News | Posted 05/10/2018

In September 2018, adalimumab biosimilar, Hulio, and pegfilgrastim biosimilar, Udenyca, received European Commission (EC) approval.

Limited distribution networks found to be anticompetitive Generics/Research | Posted 05/10/2018

Limited distribution networks, whereby a drug manufacturer has a contract with one or a small number of distributors, suppress competition in both the generic and biosimilar drug markets. This lead...

Biosimilars no longer eligible for parallel processing in Australia Policies & Legislation | Posted 05/10/2018

Biosimilars will no longer be able to request parallel processing when submitting a biosimilar application for approval in Australia.

Hospitals launch non-profit generics company Generics/General | Posted 05/10/2018

Several major hospital groups announced the official launch of their non-profit generics company, Civica Rx, on 6 September 2018. The company has been created in an effort to combat regular shortag...

Pharmacokinetics of CT-P6 in patients with HER2+ early-stage breast cancer Biosimilars/Research | Posted 05/10/2018

Researchers from Celltrion presented data that support the pharmacokinetic (PK) similarity between trastuzumab biosimilar CT‑P6 and originator trastuzumab (Herceptin) [1].

FDA releases new guidance to speed up generics approvals Guidelines | Posted 05/10/2018

The US Food and Drug Administration (FDA) has released a guidance document that aims to reduce the time that it takes for safe and effective generics to reach the market.

Biocon’s biosimilars plant gains clearance from FDA Biosimilars/General | Posted 05/10/2018

India-based biologicals specialist Biocon has stated that its biosimilars plant has received a clean bill of health, indicating that it is now compliant with US Food and Drug Administration (FDA) m...