Biosimilars/News
EMA approves first monoclonal antibody biosimilar
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 28 June 2013 that it had recommended granting of marketing authorization for the first monoclonal antibody biosimilar, marketed under two trade names, Remsima (Celltrion) and Inflectra (Hospira) with different marketing authorization, different EPAR, and different packaging.
Teva gains FDA approval for three-times-a-week Copaxone
Teva Pharmaceutical Industries (Teva) announced on 28 January 2013 the generics giant had gained US Food and Drug Administration (FDA) for a new formulation of its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).
Biosimilars ruling has implications for future patent challenges
Biosimilars manufacturers may not be able to make early challenges on biologicals patents according to a ruling which rejected Sandoz’s request to invalidate patents for Amgen’s blockbuster autoimmune disease treatment Enbrel (etanercept). This appears to be the first court decision interpreting the patent litigation provisions of the Biologics Price Competition and Innovation Act (BPCI Act).
Stada in-licenses biosimilar filgrastim
German generics giant Stada Arzneimittel (Stada) announced on 28 October 2013 that it was strengthening its activities in the biosimilars area by in-licensing a biosimilar filgrastim product from Canada-based Apotex.
EC approves first monoclonal antibody biosimilar
Hospira announced on 10 September 2013 that it had received European Commission (EC) approval for its biosimilar monoclonal antibody infliximab (Inflectra), a first in Europe.
Biocad signs deal for biosimilar darbepoetin alpha in Turkey
Russian biosimilars manufacturer Biocad has signed a definitive agreement with Turkish oncology specialist Koçak Farma for the export of biosimilar darbepoetin alpha active pharmaceutical ingredients (APIs).
Amgen to start phase III trial for biosimilar adalimumab
Biotechnology giant Amgen is to start a phase III clinical trial for a biosimilar version of adalimumab in patients suffering from severe rheumatoid arthritis according to the EU Clinical Trials Register.
EMA approves biosimilar follitropin alfa and somatropin
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 31 July 2013 that it had recommended granting of marketing authorization for a biosimilar follitropin alfa. While on 9 September 2013, the agency announced the approval of a new somatropin biosimilar.
Failed biosimilars company to be sold
The assets of biosimilars developer Elona Biotechnologies (Elona) will be auctioned on 27 September 2013 unless sold before 6 September 2013.
Celltrion applies for biosimilar infliximab approval in Japan
On 11 September 2013, South Korean biotechnology company Celltrion announced that it had filed for approval of Remsima, its biosimilar infliximab monoclonal antibody, with Japan’s Ministry of Health, Labour and Welfare (MHLW).
