Bio Boy! Developing Markets to See Surge in Biosimilar Drug Growth

The global biosimilar drug market for 2013 will see a 20% growth on last year’s figures to a whopping $2.44 billion, and a new survey indicates that this trend will continue to flourish for the next decade.



Last year, the majority of global revenues for biosimilars came from emerging markets where such products were first launched over twenty years ago.  However, according to a new report by Visiongain, growth of these ‘follow-on’ drugs in developed markets is set to surpass previous global standards over the next decade as patent expirations on many blockbuster biologics during 2013-17 are anticipated. 

The global biosimilars market’s current leading segments are: monoclonal antibody biosimilars (mAbs); insulins; interferons; erythropoetins; filgrastim; somatropin; and follicle stimulating hormone (FSH).  According to the report, the approval and release of similar products will drive impressive growth in the biosimilars space up to 2023, particularly in the US and the European Union (EU).

To date, two companies (CellTrion and Hospira) have already requested approval from the European Medicines Agency (EMA) for biosimilar antibody applications, with product launches across the EU expected in 2014.  By which time - predicts the study - many companies worldwide will be attempting to tap into the trend, with a special focus on mAbs.  Fast forward to 2023, insulin products and mAbs are expected to account for 57% of the global biosimilars market.

Many drug manufacturers, including the larger firms, such as Pfizer, Merck and Boehringer are being tempted by the biosimilars market as these drugs offer a simpler way to launch biopharmaceuticals compared with developing novel products from scratch, according to Richard Lang, a pharmaceutical market analyst for Visiongain.  “Many of these companies are focusing on biosimilar monoclonal antibody development – those three companies have clinical-stage candidates in that sector.”

Complexities and unclear regulation

The positive outlook for growth does come with a warning, as the development of the large complex molecules of biologics, regardless of cloning the original product, can often translate to a long and costly development cycle.  Unlike the more common small-molecule drugs, biologics can be quite sensitive to changes in manufacturing processes – and the companies attempting to create a biosimilar drug will not have access to the original engineering.  

As a result, very slight variations from the blockbuster drug can have serious health implications for the intended market, a concern that has fed through to reluctant policy makers and given scope for drug manufacturers to contest a copy of their innovative product.  For example, a lobby group of biotech drug companies in India has recently raised concerns about the approval of Cipla's first biosimilar drug Etanercept, used for the treatment of rheumatic disorders.

Despite the positive forecast, and in contrast to the long solidified guidelines for follow-on drugs by the EMA, launches of biosimilars in the US have faced some difficulty as the FDA has been slow to clarify certain queries around how the agency will evaluate these drugs. Released last year, the draft guidelines left numerous questions unanswered as to drug classes and definitions, safety standards, labelling etc.  More concrete, albeit strict, standards were released by the FDA earlier this year and biopharma companies won’t want to be left behind in the race against the patent cliff clock.

According to the Generics and Biosimilars Initiative, patents for 12 blockbuster biologic compounds generating a combined $67 billion in sales will expire by 2020, so these opportunistic firms will surely be fulfilling the predictions of the new survey and bombarding the agency with applications.

Alas, the obstacles don’t end even when approval is achieved, according to Lang, “The recent release of development guidelines by regulatory agencies in markets worldwide will increase the success rate of biosimilar development. However, commercializing biosimilars is as challenging as developing them. Companies will need to brand and market their biosimilars in a similar way to novel drugs, engaging key stakeholders such as doctors, health care payers and patients, to achieve high market penetration.”