Pharmacapsules @ Gowlings - April 7, 2009

Edited by Jennifer Wilkie and Chantal

Saunders

Health Canada Releases Guidance Documents for Subsequent Entry

Biologics

Natural Health Products Directorate Releases New Policy on the

Interface of Food and Natural Health Products

PMPRB Releases Revised Draft Excessive Price Guidelines

Recession's Toll On Public And Private-Sector R&D

Spending

Guidance Document: Data Protection Regulations

U.S. President Obama Appoints Commissioner of the FDA and

Creates a New Food Safety Working Group

Recent Cases

Health Canada Releases Guidance Documents for Subsequent

Entry Biologics

By: Scott Robertson

Health Canada recently released its new guidance document for

Subsequent-Entry Biologics (SEBs). In addition, a final guidance

document was released for Data Protection under the Food and

Drug Regulations, as well as proposed amendments to the

guidance documents under the Data Protection Regulations and the

Patented Medicines (Notice of Compliance) Regulations (PM(NOC)

Regulations) to reflect the new SEB guidelines.

The Data Protection Regulations and the PM(NOC)

Regulations are critical aspects of the SEB regulatory system

both for existing biologic therapies and for IP strategies on

biotechnology products going forward in Canada.

The guidance documents define an SEB as a biologic drug that

would enter the market subsequent to, and 'similar' to an

innovator product authorized for sale in Canada. The new

regulations apply to all biologic drug submissions where the

sponsor seeks authorization for sale based on demonstrated

similarity to a biologic drug that was authorized for sale in

Canada and relies, in part, on prior information regarding the

authorized innovative biologic drug in order to present a reduced

clinical and non-clinical package as part of the submission.

The policy statements included in the new guidance document

specifically state that SEBs are not "generic biologics"

and many characteristics associated with the authorization process

and marketed use for generic pharmaceutical drugs do not apply.

Authorization of an SEB is not a declaration of pharmaceutical

and/or therapeutic equivalence to the reference biologic drug.

An SEB will only be authorized if a submission demonstrates

similarity based on a direct or indirect comparison to such an

authorized innovative biologic drug. The concept of what an

indirect comparison may constitute will no doubt create discussion

amongst sponsors looking for approval of SEBs. The basis for a

product being authorized as an SEB hinges on the ability to

demonstrate similarity to a suitable reference biologic drug.

In order to provide flexibility to sponsors, Health Canada has

provided a mechanism to be used in appropriate and special

circumstances, to permit the use of a reference biologic drug that

is not authorized for sale in Canada which can still be used in the

demonstration of similarity between the SEB and the product

authorized for sale in Canada. However, where a non-Canadian

reference product is used, the submission must explicitly and

clearly explain the link between the reference product and the

product authorized for sale in Canada.

If a non-Canadian reference biologic product is considered, the

new guidance documents state that non-Canadian product should be

widely marketed in a jurisdiction that formally adopts

International Conference on Harmonization (ICH) guidelines and has

regulatory standards and principles for evaluation of medicines,

post-market surveillance activities, and approaches to

comparability that are similar to Canada.

Finally, in order for a sponsor to sufficiently explain the link

between the non-Canadian reference biologic drug and the version of

the product authorized for use in Canada, it must document in its

submission that the non-Canadian reference biologic drug is

marketed by the same innovator company or corporate entity which is

approved to market the medicinal ingredient in the same dosage form

in Canada, or that it is marketed through a licensing arrangement

with the innovator company or corporate entity which currently

markets the version of the product approved in Canada.

Once a notice of compliance (NOC) is granted, the SEB is a new

biologic drug and regulated like any other new biologic drug.

Therefore, an SEB cannot be used as a reference biologic drug.

Detailed and comprehensive product characterization will need to

be provided by a sponsor in order to demonstrate similarity. The

following additional criteria will be used to determine the scope

of eligible products:

a suitable reference biologic drug exists that: a) was

originally authorized for sale based on a complete data package and

2. has significant safety and efficacy data accumulated such that

the demonstration of similarity will bring into relevance a

substantial body of reliable data;

the product can be well characterized by a set of modern

analytical methods; and

the biologic drug, through extensive characterization and

analysis, can be judged similar to the reference biologic drug by

meeting...