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Switching and extrapolation of subsequent entry biologics in Canada

The regulatory framework for biosimilars in Canada explains how their substitutability and/or interchangeability are governed in the country. Biosimilars, which are known as subsequent entry biologics (SEBs) in Canada, are regulated in line with guidance from the World Health Organization.

Efficacy, extrapolation and interchangeability of biosimilars

Biosimilars have been available in Europe for more than seven years; despite this fact, physicians still have concerns about the use of biosimilars. Some of their concerns have been discussed by members and experts of the Working Party on Similar Biologic Medicinal Products of the European Medicines Agency (EMA) [1].

Safety concerns limit similar biologics uptake in India

How do concerns about the safety of domestic biologicals limit the uptake of ‘similar biologics’ in India? This is a question that author Malipatil tried to address in his review of similar biologics in India [1].

Differences between biosimilars and reference products

A review of glycosylated biosimilars approved in the European Union (EU) and Japan has highlighted structural variances between biosimilars and their reference products [1].

Pharmacovigilance for biologicals in The Netherlands

Escher is an independent regulatory research platform run by Netherlands-based research enabler TI Pharma. The group recently published a paper in the journal Drug Safety on the traceability of biologicals in clinical practice and adverse drug reaction (ADR) reporting [1]. This paper concludes that in The Netherlands brand names are not routinely recorded in clinical practice and batch numbers are poorly recorded. The findings suggest that the limited traceability of brand names and batch numbers in ADR reports for biologicals may be primarily caused by the shortcomings in the recording and tracing of information in clinical practice.

Barriers to biologicals competition

As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to ‘large molecule’ biologicals. Although biologicals represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by the US Congress in 2010 is unlikely to yield significant cost savings.

Adalimumab biosimilar meets primary endpoint in pharmacokinetic study

On 21 December 2015, Baxalta, a spinoff company from Baxter International, and US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced positive results from a pharmacokinetic study with their candidate adalimumab biosimilar M923.

Positive phase III results for cetuximab and infliximab copy biologicals

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 11 January 2016 that its partner, MabTech had successfully completed phase III clinical trials in China for STI-001, a copy biological for cetuximab (Erbitux) and STI‑002, a copy biological for infliximab (Remicade). Both STI-001 and STI-002 met their primary endpoints in confirmatory, randomized, controlled, two-part phase III studies.

Lack of health insurance limits access to biologicals in India

One example of a negative driver of the ‘similar biologics’ market in India is the lack of health insurance in the country [1].

Factors affecting the uptake of ‘similar biologics’ in India

In his review of similar biologics in India, Dr Nagaraj Malipatil, a clinical pharmacologist from Bangalore, attempted to address what are the drivers and the limitations to the ‘similar biologics’ market in India [1].