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Pharmaceutical price regulation in Saudi Arabia: a countdown to affordable biosimilars

The pricing of pharmaceuticals and biosimilars is generally subject to national regulatory control. Regulation is in place to ensure pharmaceutical affordability, yet enable profitability for pharmaceutical companies and facilitate innovation. A recent paper on pharmaceutical price regulation in Saudi Arabia by Alhomaidan et al. [1], charts the regulatory procedures in place, and outlines how their evolution has led to today’s regulated pricing of biosimilars.

Positive phase III results for Amgen’s trastuzumab biosimilar

Results of a study of Amgen and Allergen’s trastuzumab biosimilar (ABP 980) compared to Herceptin (trastuzumab) have ‘ruled out inferiority’, according to the company.

Positive clinical data for three anti-TNF-α biosimilars

Results of studies of three biosimilars from Samsung Bioepis, Benepali (etanercept), Flixabi (infliximab) and candidate biosimilar SB5 (adalimumab), have shown ‘comparable outcomes with regards to both the efficacy and safety of treatment’ when compared to their respective reference products, according to the company [1-3].

Mylan presents comparability data for trastuzumab biosimilar

Generics giant Mylan Pharmaceuticals (Mylan) presented robust data from its biosimilar trastuzumab programme at the American Society of Clinical Oncology (ASCO) Annual Meeting ASCO 2016 held in Chicago, USA on 3–7 June 2016.

Epoetin alfa biosimilar effective in treating anaemia

Authors of a post-marketing study of the epoetin alfa biosimilar Retacrit say that the biosimilar is effective and well tolerated in treating chemotherapy-induced anaemia (CIA) [1].

Pharmacovigilance of biologicals in Denmark

As a result of the increasing use of biologicals and biosimilars in Denmark, the Ministry of Health (MoH) in partnership with the country’s regulatory agency has set up an action plan to monitor biologicals and improve pharmacovigilance, as well as to improve understanding among healthcare professionals and patients [1].

Evolution of biosimilars in developed and developing countries

The development of biologicals has experienced continuous growth over the past three decades. The expiration of patent protection for many biologicals has led to the development of biosimilars in many countries around the world. This paper reviews the literature on biosimilars and covers their therapeutic status, clinical trials, approved biosimilars and regulatory guidelines in Japan, South Korea and Malaysia [1].

Biosimilars: the benefits need to be communicated

Extrapolation may be the most contentious issue of biosimilar development, but it is also its single greatest benefit, says Dr Martina Weise of the Federal Institute for Drugs and Medical Devices in Germany.

Biosimilars: clinicians and regulators need to talk

In Europe, there is a clear gap between the regulatory decisions that govern biosimilar approval and the recommendations of medical societies. The fact that the views of medical societies, whose members are the physicians that will prescribe biosimilars, disagree with those of regulators, threatens to hold back biosimilar uptake. 

Pure red cell aplasia in a CKD patient after treatment with epoetin zeta

Authors from the Versilia and Manzoni Hospitals in Italy report the case of a patient who developed pure red cell aplasia (PRCA) following subcutaneous administration of epoetin zeta, which is one of the two biosimilars of epoetin alfa licensed in Europe [1].

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