Biosimilars
Will the unclear path of biosimilar interchangeability become clearer?
Biosimilar use has led to increased access to biological treatments for some molecules wherein switching from originator to biosimilar has been one means to exchange products [1, 2]. Another but less applied way to exchange the products is via substitution by a pharmacist, i.e. without informing the prescriber [2]. Substitution of biosimilars is a topic with many contrasting views and has been highly debated [3-12]. More clarity on the matter is needed because health care has reached a point where policy decisions need to be made about whether substitution should become a practice in biosimilar use. Therefore, researchers from Denmark, Sweden and The Netherlands investigated the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars [13].
Biosimilars approved in Argentina
In Argentina, the regulatory agency in charge of approving biological drugs is the National Administration of Drugs, Food and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT).
Generium launches omalizumab (Xolair) non-originator in Russia
Moscow’s Generium has launched a non-originator biological of omalizumab (Xolair) on the Russian market, the third of Generium’s products using Selexis’ SUREtechnology Platform to reach the market.
Europe’s IP framework should support earlier authorization of biosimilars, review finds
A review of the European Pharmaceutical Strategy suggests the framework should focus on intellectual property (IP) initiatives that support the earlier authorization of biosimilars.
Key considerations when switching to biosimilar insulin
Biosimilar insulins can offer a cheaper alternative to originator insulators and substantial savings for healthcare systems. A recent ‘Quick guide: Initiating or switching to a biosimilar insulin’, [1] published in the Journal of Diabetes Nursing, outlines key aspects to consider when switching.
Biosimilars and non-medical switching among Saudi rheumatologists. The knowledge gap
The increasing cost of originator biologicals, combined with consequences of the COVID-19 pandemic, have burdened the healthcare system. Unfortunately, the biosimilar uptake in Saudi Arabia has not reached an optimal level despite the approval of several agents. Therefore, physicians are essential stakeholders in the process and acceptance of biosimilars.
Nova Scotia, Canada implements biosimilar switching policy
Nova Scotia becomes the fifth Canadian province to implement a biosimilar switching policy, meaning that half of Canada’s provinces have now implemented such policies.
The US needs to learn from Europe to increasing access to biosimilars
Europe has been leading the way when it comes to encouraging the use of biosimilars. This is especially true in Scandinavian countries, such as Norway, which are seen as leading the way when it comes to switching and substitution of biosimilars in Europe [1]. In fact, an analysis by Norwegian researchers has found that ‘tremendous savings’ could be realized in the US should the country implement similar strategies [2].
EMA recommends approval of teriparatide and pegfilgrastim biosimilars
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 28 January 2022 that it had recommended granting of marketing authorization for the teriparatide biosimilar Sondelbay and the pegfilgrastim biosimilar Stimufend.
Amgen predicts a steady flow of biosimilar launches
Amgen CEO Robert Bradway predicted expanding the company’s biosimilars business with a steady flow of biosimilar launches at the J.P. Morgan Healthcare Conference, which was held on 11 January 2022.
