The interest in developing biosimilar medicines has grown dramatically in recent years with biotech drugs gradually increasing their share of the overall therapeutics market worldwide to account for an attractive portion of the sales pie. As blockbuster biopharmaceuticals, such as Avastin, Enbrel, Erbitux and Humira, lose their patent protection over the next 10 years, the market for follow-on biologics or biosimilars will become an even more lucrative proposition. Unfortunately, the model for developing and commercialising a biosimilar is not the same as that of a generic medicine; it is far lengthier and more costly. Furthermore, a specific regulatory pathway has yet to be defined in many countries, including the US, which has deterred many companies from taking the plunge and investing in this area. As an additional obstacle, prescribers, who acknowledge the greater complexities involved in developing a biopharmaceutical, are erring on the side of caution, the majority opting to wait until sufficient pharmacovigillance data has been collected to convince them of a biosimilar's safety. This is an admirable stance, but in an environment where healthcare payers are constantly under pressure to reduce costs, is it sustainable?
This month we delve into the complex topic of biosimilars. Split into two parts, in this issue, we look at the complex regulatory environment for biosimilars and examine the obstacles to market entry. We also asked the Senior Director Scientific Affairs at the European Generic Medicines Association what steps that have been taken in Europe to improve access to biosimilars and to inform us of the work that has been done so far towards a harmonised regulatory approach. Next month, we speak to the companies that have first-hand experience of launching biosimilars and ask the question: is it worth it?
I hope you gain some valuable insight into this fascinating area.
Fedra Pavlou, Editor-in-Chief
Send your questions and comments by email to [email protected]