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Biosimilars: implications for oncologists Biosimilars/Research | Posted 13/07/2018

In 2015, the US Food and Drug Administration (FDA) approved its first biosimilar, filgrastim-sndz, a biosimilar of the granulocyte colony-stimulating factor filgrastim. Since then, FDA has approved...

Pfizer gains Japanese approval for infliximab biosimilar Biosimilars/News | Posted 13/07/2018

Pfizer Japan announced on 2 July 2018 that it had gained Japanese approval for its infliximab biosimilar.

Analytical consideration in demonstrating similarity for biosimilars Reports | Posted 13/07/2018

According to the US Food and Drug Administration (FDA) guideline on ‘Scientific Considerations in Demonstrating Biosimilarity to a Reference Product’ [1], ‘FDA expects that first, a sponsor will ex...

Generic sofosbuvir and daclatasvir bioequivalent to originators Generics/Research | Posted 13/07/2018

With the aim of eliminating hepatitis C (HCV) by 2030, some originator pharmaceutical companies have granted voluntary licences to generics companies to mass produce the direct-acting antivirals (D...

Hatch aims to promote biosimilars and generics and restrict litigation Policies & Legislation | Posted 13/07/2018

Senator Orrin Hatch filed an amendment to the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which was advanced to the Senate by the Judiciary Committee on 14 June 2018.

Positive results for infliximab and trastuzumab biosimilars Biosimilars/Research | Posted 13/07/2018

Celltrion Healthcare (Celltrion) and Samsung Bioepis have both announced positive results for their infliximab and trastuzumab biosimilars, respectively.

US pharmacies sue J&J for stifling infliximab biosimilars Biosimilars/General | Posted 13/07/2018

Two major US pharmacy chains, Walgreen and Kroger, have sued healthcare giant Johnson & Johnson (J&J) in the US District Court Eastern District of Pennsylvania. The pharmacies allege that J...

FDA approves first Suboxone generics for opioid dependence Generics/News | Posted 13/07/2018

The US Food and Drug Administration (FDA) announced on 14 June 2018 that it had approved the first generics of Suboxone (buprenorphine/naloxone) sublingual film (applied under the tongue) for the t...