More Articles

Bioequivalence of bevacizumab biosimilar (BEVZ92) versus Avastin in mCRC patients Biosimilars/Research | Posted 28/09/2018

Researchers from mAbxience presented data that supports the pharmacokinetic (PK) bioequivalence between bevacizumab biosimilar BEVZ92 and originator bevacizumab (Avastin) as first-line treatment in...

EMA approves pegfilgrastim biosimilars Fulphila, Pelmeg and Ziextenzo Biosimilars/News | Posted 28/09/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 21 September 2018 that it had recommended granting of marketing authorizations for the pegfi...

Generic hepatitis drug effective in patients with or without HIV Generics/Research | Posted 28/09/2018

Over 3% of people with hepatitis C infections also have HIV. A new study conducted in Taiwan shows that generic versions of the hepatitis C treatment Epclusa are equally effective in patients with...

Adalimumab copy biologicals accepted for review in China Biosimilars/News | Posted 28/09/2018

China Food and Drug Administration (CFDA) has accepted applications for approval of adalimumab copy biologicals from Hisun Pharma (Hisun) and Bio‑Thera Solutions (Bio‑Thera).

Recommendations for biosimilars in rheumatology in the Middle East Biosimilars/Research | Posted 28/09/2018

The increasing availability of biosimilars in Middle Eastern regions may provide an opportunity to increase the number of rheumatology patients who have access to traditionally more expensive biolo...

MENA mAb manufacturer AryoGen receives EU GMP approval Pharma News | Posted 28/09/2018

Iran-based AryoGen Pharmed (AryoGen) has received a Good Manufacturing Practice (GMP) certificate from the European Medicines Agency (EMA), becoming one of the first monoclonal antibody (mAb) manuf...

Samsung Bioepis sued over trastuzumab biosimilar but win for Celltrion’s biosimilar Inflectra Biosimilars/General | Posted 28/09/2018

Roche’s Genentech has sued Samsung Bioepis regarding its trastuzumab biosimilar, but Celltrion has won its patent battle against Johnson & Johnson (J&J).

FDA approves first EpiPen generic amid shortages Generics/News | Posted 28/09/2018

The US Food and Drug Administration (FDA) announced on 16 August 2018 that it had approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment...