More Articles

Australia’s TGA will keep same names for biologicals Policies & Legislation | Posted 01/02/2019

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has decided to keep the same names for biologicals.

Tanvex BioPharma submits filgrastim biosimilar to Health Canada Biosimilars/News | Posted 01/02/2019

Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) announced on 16 January 2019 that it had submitted a biosimilar application to Health Canada for its proposed filgrastim biosimilar TX01.

Liability chain of biosimilar switching Biosimilars/Research | Posted 01/02/2019

When an adverse event to a medicinal product, or a loss of efficacy, is experienced by a patient, the liability chain may potentially involve both the manufacturer and/or Marketing Authorization Ho...

Generics applications under review by EMA – January 2019 Generics/General | Posted 01/02/2019

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centrali...

FDA approves trastuzumab biosimilar Herzuma Biosimilars/News | Posted 01/02/2019

On 14 December 2018, the US Food and Drug Administration (FDA) approved the trastuzumab biosimilar, Herzuma (trastuzumab-pkrb), for the treatment of patients with human epidermal growth factor rece...

European SPC waivers come closer to becoming a reality Guidelines | Posted 01/02/2019

A European committee has voted in favour of waivers for Supplementary Protection Certificates (SPCs)

Adalimumab biosimilar Imraldi makes waves in Europe Biosimilars/General | Posted 01/02/2019

Korean biosimilars maker Samsung Bioepis has gained more than 60% of the adalimumab market in Germany for its adalimumab biosimilar, Imraldi. But it’s not just Imraldi and not just in Germany, the...

Teva receives FDA approval for Sabril and launches Elidel cream Generics/News | Posted 01/02/2019

In January 2019, Teva Pharmaceutical Industries (Teva) received US Food and Drug Administration (FDA) approval for its first generic version of Sabril (vigabatrin) and launched a generic versi...