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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].

Prescribing similar biotherapeutic products in Latin America

Prescribing practices vary across different countries in Latin America and reveal gaps in understanding and in the use of distinguishable names for biologicals [1].

Partnerships driving similar biologics development in India

With biosimilars grabbing an increasing share of the global biologicals market and with India providing a cheaper place to carry out research and development, more international players are partnering with Indian companies.

Doctors in the US should remember to prescribe generics

According to the findings of a literature review carried out by the American College of Physicians (ACP) the major obstacle to increased use of generics in the US is patient and provider perceptions.

Domestic biologicals cost less in India

One of the factors increasing the use of similar biologics in India is the fact that domestic biologicals cost much less than the originator brand-name biologicals [1].

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.

Low costs and less stringent regulatory requirements in India

Dr Nagaraj Malipatil, a clinical pharmacologist, from Bangalore, India in his review of ‘similar biologics’ in India, outlines some of the drivers of the ‘similar biologics’ market in India [1].

Pegfilgrastim biosimilar as safe and effective as Neulasta

Sandoz, the generics division of Novartis, announced on 7 December 2015 positive results from a phase III study of its pegfilgrastim biosimilar (LA-EP2006).

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].