Home / Biosimilars / Research


Standards for biosimilars or ‘alternative’ biologicals in India

In the highly regulated market of the EU clear and rigorous guidelines exist for approval of biosimilars. In the EU biosimilars must ensure the same quality, safety and efficacy, as any other product, along with demonstrating biosimilarity (comparability) with the reference product.

Immunogenicity of biosimilar low molecular weight heparins

In a presentation by Professor JM Walenga and colleagues from the Loyola University Medical Center, Illinois,USA, 'immunogenicity issues faced by biosimilar low molecular weight heparins (LMWHs)' were discussed [1].

Timing of the launch of biosimilars in Europe

When and where to launch a new biosimilar to ensure that its uptake is the most effective throughout Europe is an issue that affects all pharmaceutical companies working on biosimilars [1].

Challenges ahead for biosimilar development

Biosimilars, it seems are here to stay, but there is still some way to go before they become commonplace. There is also concern over the associated costs for biological medicines. The cost of biotech therapies is expected to steadily grow by about 30% (an approximately 20 fold increase in 10 years) by 2016.

How cheap will biosimilars need to be

What level of discounts will biosimilars need to provide to be competitive? Some believe that biosimilars will need to provide substantial discounts, being priced as low as 25%, and not 75%, of the originator price [1].

Biosimilar regulatory issues

In Europe, the regulatory frameworks for biosimilars are largely established, with both general guidelines and product specific guidelines put in place by the EMA, covering human insulin, somatropin, human growth hormone, erythropoietin, interferon-alpha, low molecular weight heparin and monoclonal antibody. The agency is also currently working on draft guidelines for a number of other product class specific guidelines, including interferon-beta and follicle stimulation hormone.

Manufacturing of biosimilars

Manufacturing of biosimilars is more challenging than the traditional small molecule generics. Some of the reasons are:

  • Investments (including operating costs) associated with manufacturing of biosimilars along with the risk of failure for biosimilars are significantly higher than that for small molecule generics. This results in a relatively smaller discount for biosimilars compared to small molecule generics.
  • Minor changes in manufacturing process can cause significant changes in efficacy or immunogenicity.
  • Biosimilars are larger and more complex molecules to manufacture.

Opportunities for biosimilars in emerging markets

By 2015, IMS Health expects spending on biosimilars to exceed US$2 billion annually, or about 1% of total global spending on biologicals [1]. This growth in biosimilars will be driven mainly by patent expiries coming in the next five years. However, due to the complexity and cost of developing biosimilars for western markets many biosimilar manufacturers are turning to emerging markets as being a much more cost-effective solution.

Doctors wary of using biosimilars for extrapolated indications

A report published on 24 August 2011 by research and advisory firm Decision Resources finds that the majority of US and European physicians are wary of using a biosimilar for an indication for which supporting clinical data are lacking.

Controversial nomenclature for new biosimilars

How will FDA chose to name biosimilars? The answer it appears is not simple and could greatly affect the marketing costs associated with these products [1].

Generics News Research General


Biosimilars News Research General