Gabriele Dallmann's Commentary on EU Regulatory News: Biosimilar infliximab / CD52 mAb in MS / ATMP / Cangene / tofacitinib / axial ankylosing spondylitis / EMA approval numbers

Recently, we all witnessed a historic regulatory milestone as end of June 2013 the CHMP, the scientific committee of the EMA, the European Medicines Agency, has given a positive opinion on the first biosimilar monoclonal antibody in the ICH regions EU, US, Japan. The product is a biosimilar to the reference product infliximab – marketed as Remicade by Janssen Biologics. The Korean bisoimilar pioneer company Celltrion has developed this product and in the EU it has been applied for marketing authorisation for two products, Remsima for Celltrion Healthcare Hungary and Inflectra for Hospira UK.  The Co-/Rapporteurs of the CHMP for the review procedure were appointed from UK and Finland. 

VIDEO: The positive opinion of the EU CHMP on the first biosimilar infliximab in the ICH region WATCH NOW!

What else is worthwhile to mention regarding biopharmaceuticals from the June CHMP?

Alemtuzumab is back! This monoclonal antibody directed to CD52 expressed on normal and malignant T- and B lymphocytes was once approved as MabCampath for B-cell chronic lymphocytic leukaemia (B-CLL) but withdrawn from the market by the Marketing Authorisation Holder in 2012. Now, Genzyme has received a positive opinion for alemtuzumab with Lemtrade as trade name for the use in multiple sclerosis.

And we have another positive opinion for an ATMP! With some delay to the FDA approval Dendreon has received the positive for Provenge, an ATMP comprising autologous peripheral blood mononuclear cells activated with pap-gm-csf (sipuleucel-T) for the use in metastatic castration-resistant prostate cancer.

Cangene withdrew its application for IXinity (trenonacog alfa), a recombinant human factor IX for the treatment and prevention of bleeding in patients with haemophilia B. Despite sufficient evidence shown for clinical efficacy it could not be considered to show a positive benefit risk ratio as the product had induced an unexpectedly high level of antibodies against the host cell protein – the protein from the cells used to manufacture the product. Although the company did refine the manufacturing process to remove these proteins, a further study was recommended by the CHMP.
By the way, in July the CHMP has confirmed the negative opinion on Pfizer’s tofacitinib for use in Rheumatoid arthritis (which has an FDA approval in the US) whereas the FDA Advisory Committee did not recommend Abbvie’s Humira for axial ankylosing spondylitis which is approved in the EU.

The EMA in the first half of 2013 has adopted 44 positive opinions, 5 thereof for designated orphan medicines, 2 ATMPS, 19 other new medicines, 2 biosimilars, 3 hybrid products and 13 generics and informed consent applications. 39 initial evaluations have started, among them 4 designated orphan medicines, 1 ATMP and 1 biosimilar. We will analyse the ratio of biopharmaceuticals versus new chemical entities and comment more on that in the future.

Enjoy your summer break!

Dr. Gabriele Schaeffner-Dallmann
EUCRAF Founder and Study Director, Ex-Regulator (PEI), Biopharmaceutical Expert