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The National Institute for Health and Care Excellence (NICE) again recommends against Roche’s application for pertuzumab as an adjuvant treatment in patients with a high risk of recurrence. NICE confirmed its earlier findings that pertuzumab is unlikely to be cost-eff...

Celltrion set to commence Phase III Clinical Trials for BmAb biosimilar in 150 sites across Europe, Asia and South America.

Amgen files third suit against Apotex based on aBLAs for biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim).  The patent under scrutiny, US Patent No. 9,856,287 was issued on 2 January this year and therefore was not included in earlier ‘patent dances...

Amgen files third suit against Apotex based on aBLAs for biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim).  US patent 9,856,287 was issued on 2 January 2018 and was not included in earlier ‘patent dances’.  With three additional pending patent...

Celltrion announces Phase I and III trials for AmAB biosimilar across 75 sites in 8 European nations, expected to be completed by 2020.

iBio and CC-Pharming enter agreement to develop biosimilar rituxumab for the Chinese market.

Clover announces that Phase I trials of a potential etanercept biosimilar are underway.

Intas announces subsidiary Accord Healthcare will release pegfilgrastim biosimilar across Europe after receiving a positive response from the Committee for Medicinal Products for Human Use.

Pfizer announces EMA approval of biosimilar trastuzumab, Trazimera® for the treatment of human epidermal growth factor (HER2+) breast cancer and HER2+ metastatic gastric or gastroesophageal junction adenocarcinoma.  This is Pfizer’s 4th biosimilar to receive EU approv...

AU’s PBAC has confirmed that Amgen and Samsung’s biosimilar adalimumab (respectively Amgevita and Hadlima) will be “A-flagged”, enabling pharmacy substitution.