The end of July 2012 proved exciting for the world of biosimilar manufacturers. However, for the regulatory officials worldwide it meant more uncertainty and unknowns about proper, global biosimilar guidelines.
On July 23, 2012, South Korean biosimilar manufacturer Celltrion announced the approval of Remsima (CT-P13), a biosimilar antibody, by the Korean Food and Drug Administration.
Remsima is a biosimilar version of Johnson & Johnson’s Remicade (infliximab) which was one of the first monoclonal antibody TNF inhibitors approved for the treatment of Rheumatoid Arthritis (RA).
Remsima is approved for several indications and will be marketed in Asia and South America by the end of the year. In Europe, Celltrion filed for market authorization with partner Hospira to launch Remsima under the name of Infectra.
Interestingly, Remsima is only the first officially approved biosimilar antibody for RA therapy as Reditux, a MabThera biosimilar, was launched in India in 2007, but under unapproved biosimilar development guidelines.
The first-ever approved biosimilar, Omnitrope (somatropin), arrived on the European market in 2006.
Since then 14 more drugs across the drug classes of human growth hormone, granulocyte stimulating factor, and erythropoietin have been approved in the European Union (EU).
The definition of a biosimilar drug according to the World Health Organization is as follows: a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product.
This definition seems straightforward, but guidelines to maintain the safety and efficacy of these drugs have been difficult to draft and approve worldwide.
The issues which have come under scrutiny include questioning of the biosimilar formulation, the amount of clinical trial data needed, and quality control of manufacturing practices.
Without a global resolve and understanding of the clinical and regulatory factors involved in designing and marketing a biosimilar drug, the market uptake will likely be slow.
With several antibodies coming off patent in the next few years, biosimilars will be waiting in the wings to take some revenue, but they are not likely to cannibalize the market due to the uncertainties which have been in question.
Even though the biosimilar market earned about $170m in 2010, uptake will be slow compared to generics for reasons stated, while considerable investment is also needed to produce a biosimilar and bring it to market.
In order for biosimilars to become competitive, price reduction strategies could likely grab the attention from consumers, physicians, and payers, which could increase the biosimilar market share.
However, due to high manufacturing costs, biosimilar drugs are less likely to be included in discount offerings which generic drugs are accustomed to.
Since the upcoming biosimilars are from different drug classes than those currently on the market, there will be supply and demand drivers.
Companies will be trying to get the leg-up on cost-saving strategies and maximize their potential to lead in quality assurance of the production of biosimilars.
Pharmaceutical and generic manufacturers are entering this arena, and some are being guided by Contract Research Organizations (CROs) to aid in market strategy specific to biosimilars.
Big Pharma companies such as Amgen, Biogen Idec, and Merck are competing with well-known generics companies which include Hospira, Teva, and Watson.
The CRO guidance is coming from familiar organizations such as Biocon, Harvest Moon, and Quintiles. Other potential players looking for a piece of the biosimilar pie include Astra Zeneca, Fujifilm, and GE Healthcare.
In 2011, the US was responsible for 36% of the worldwide biologic drug sales, while the five major European markets collectively took second with 22%.
Currently, it is estimated that the biosimilar market will reach close to $4 billion by 2017. The US is lagging behind with legislation and regulations for the approval and marketing of biosimilars as compared to the EU, Japan, and numerous other developed countries that have had terms in place for several years.
GlobalData believes that, if the US healthcare system and US FDA are unable to design and approve regulatory guidelines for biosimilar drugs within the next few years, the US healthcare system will lose more money, and be forced to pay for more expensive brands.