Regulatory Index News: 23/01/2018

Welcome to your Regulatory Index News update this Monday. Please take a read here to keep up to date with industry news.

First EU approval for an Avastin Biosimilar

The European regulators have approved Amgen and Allergan’s Mvasi, making it the first biosimilar of Avastin that has been approved in the EU. It has been approved with a number of indications including colon or rectal carcinoma, breast cancer, nonsquamous non-small cell lung cancer and renal cell cancer as well as several others. The approval was based on trial data which showed a high degree of similarity between Mvasi and Avastin, whereby no clinically meaningful differences were found in efficacy, safety or immunogenicity. This leaves the biosimilar cleared in both the US (September 2017) as well as the EU, allowing a different treatment option for patients. If you would like to read more on this, please click here for a PharmaTimes article.

Novartis’ Kymriah granted priority review and accelerated assessment in US and EU

The US and EU are giving the CAR-T therapy, Kymriah, a speedy review for two distinct indications in non-Hodgkin lymphoma and B-cell ALL. In the US, the FDA have granted a priority review for use as a therapy to treat adult’s ineligible for or relapse after autologous stem cell transplants. Where in the EU, the EMA are facilitating an accelerated assessment for treatment of children and young adults with r/r B-cell acute lymphoblastic leukaemia and adults with r/r DLBCL that are ineligible for autologous stem cell transplants. This CAR-T therapy offers a patient-specific manufactured treatment that targets the patient’s cancer cells and has shown to be very effective in causing remission. Please click here to read further in a PharmaTimes article.

Sanofi to refund Philippines for unused Dengvaxia doses

The Dengue vaccine has been suspended for one year in the Philippines after it was deemed that it did not comply with post-marketing requirements. However, due to the growing demand from officials and lawmakers, Sanofi has agreed to refund the Philippine government for the Dengvaxia doses they have not used which is worth around 1.4billion Phillipine pesos ($28 million or £20 million). Whilst Sanofi assure that the vaccine is safe, and that the reimbursement decision was not related to safety or quality issues of the vaccine, there are still safety questions being raised after autopsies were performed on children that had been administered Dengvaxia. Whilst no causal links have been made, these autopsies showed that common causes of death were consistent with severe dengue. Please click here to read more from a FiercePharma article. 



Max Lymbery

Date Published

23rd January 2018

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