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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.

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].

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).

Regulation and uptake of ‘similar biologics’ in India

India has, by far, demonstrated the greatest acceptance of ‘similar biologics’. But what are the drivers and the limitations to the ‘similar biologics’ market in India? This is a question Dr Nagaraj Malipatil, a clinical pharmacologist, from Bangalore, India tried to address in his review of similar biologics in India [1].

Assessing the immunogenicity of monoclonal antibodies

Safety is a major concern when it comes to biologicals (including biosimilars) and the most critical safety concern is immunogenicity. This is especially important in monoclonal antibody (mAb) biologicals, which are large molecules with complex structures and functions and which represent the largest class of biologicals [1].

Positive phase III results for adalimumab biosimilar

US-based biologicals giant Amgen announced on 9 November 2015 that results from a phase III study of its adalimumab biosimilar (ABP 501) had ‘met the primary endpoint’.

AE reporting for biologicals

Researchers from the Tufts Center for the Study of Drug Development (Tufts CSDD) sought to answer [1] examined primary suspect reports sent to the US Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) from US reporters for two biologicals that have lost patent exclusivity – somatropin and human insulin. The study was carried out to inform both FDA and the global drug development community about how naming of biosimilars might affect the traceability of adverse events (AEs).

Positive phase III results for etanercept biosimilar

On 9 November 2015, biopharmaceutical specialists Coherus and Baxalta (a spin-off company from Baxter International) announced positive results from a phase III study of its etanercept biosimilar (CHS-0214).

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