New article published in Journal of Cutaneous Medicine and Surgery (JCMS) provides an understanding of the regulatory pathway and trials used for Subsequent Entry Biologics (SEBs) in Canada

MISSISSAUGA, ON, Sept. 26, 2013 /CNW/ - A new paper published recently in the Journal of Cutaneous Medicine & Surgery (JCMS) provides Canadian clinicians with an understanding of the regulatory pathway and trials used for subsequent entry biologics (SEBs) in Canada.

The article's authors believe that with several biologic patents set to expire in the coming years, new manufacturers will enter the Canadian marketplace with SEBs. As such, there is a need for greater understanding and discussion among clinicians as to how SEBs will be adopted and used in Canadian clinical practice. The article focuses specifically on preparing for SEBs in the therapeutic areas of dermatology and rheumatology in Canada.

Biologics are the backbone of therapy for many patients under the care of dermatologists and rheumatologists in Canada.  While costs are an important consideration when evaluating these therapies, patient safety and efficacy have been guiding principles surrounding their development. Importantly, SEBs are similar but not identical to the original innovator drug and there are inherent complexities both within the large molecule itself as well as the manufacturing process that should be taken into account.

Entitled "Preparing for Subsequent Entry Biologics (SEBs) in Dermatology and Rheumatology in Canada" the article discusses the issues and practical considerations regarding the evaluation of safety and efficacy of SEBs as they are introduced to the Canadian marketplace.  The article includes an overview of various issues, including understanding Health Canada's approach to assessing SEBs, which includes clinical trial requirements to demonstrate similarity, the determination of comparative bioavailability, clinical safety and efficacy trials, the evaluation of immunogenicity, extrapolation of indications, naming and traceability, post-marketing pharmacovigilance, manufacturing and supply.

About Biologics and SEBs
Health Canada defines a biologic drug as being derived through the metabolic activity of living organisms. Biologics tend to be significantly more variable and complex in structure than chemically synthesized drugs because they are made from living organisms or cells (animal, bacteria and yeast). Biologics are sensitive to minor changes in the manufacturing process. In fact, Health Canada states that even slight differences in certain manufacturing processes may result in product variation.¹ A biologic drug that is not the original innovator drug and is developed by a different manufacturer is referred to as a Subsequent Entry Biologic (SEB) in Canada.

Due to the complex structure and manufacturing of biologics, health authorities around the world have recognized the need for distinct approval pathways for SEBs. Europe was the first to develop a distinct approval pathway for SEBs, and in 2006 the European Medicines Agency issued guidelines outlining the requirements for a demonstration of similarity between two biological medicines. Health Canada's approval process for SEBs is aligned with the biosimilar approval process set forth by the European Medicines Agency. To date, one SEB has been approved in Canada: Omnitrope^® (somatropin), a human growth hormone.

An Important Evolutionary Phase
The article concludes that the availability of SEBs in Canada will represent an important phase in the evolution of biologic therapeutics. Decisions on how to determine their place in clinical practice for biologic-naive patients and those who already receive biologics should be made on a case-by-case basis, taking into account the patient's needs, the characteristics of the specific biologic required for the patient's condition, and the clinical development program of the SEB.

SEBs will offer physicians and patients in Canada new treatment options alongside existing innovative biologic products.  Once available, issues regarding drug cost, provincial and private drug insurance, as well as provincial decisions on potential interchangeability will need to be further explored according to the authors' conclusion.

The article was supported in part by Amgen Canada Inc., a biotechnology company developing both innovative biologic and SEB medicines.

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1} Health Canada. Guidance for sponsors: Information and submission requirements for subsequent entry biologics (SEBs).  2010.  Minister of Health.

SOURCE: beSPEAK Communications

For more information or to order a reprint of the article, please contact:

Mary-Anne Cedrone
beSPEAK Communications Inc.
[phone]
[email protected]