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Our Medicines

The Next Generation of High Quality

Cost-Saving Medication – Complex Generics

A Complex Generics is a new cost-saving version of a “specialty” brand-name product used to treat chronic and complex conditions such as asthma, hypertension and osteoporosis among others. Complex Generics are products with multiple active ingredients, formulations or routes of delivery, and each one is required to include ongoing Patient Support Programs.  Creating and manufacturing complex generics involves higher levels of expertise, planning, development and cost than standard generics.
 
CGPA member companies have made significant investments in the R&D, manufacturing, clinical trials, and programs and services to launch these new products and introduce hundreds of millions of dollars in potential savings.  The industry forecasts that over the next several years Complex Generics will represent most of the new generic products launched in Canada. The commitment to an increased use of the next generation of high-quality cost-saving medication will significantly contribute to a sustainable healthcare system and a vital domestic industry.

Medicines

The Timeline to Bring New Generic Prescription Medicines to Canadians

01

Securing Active
Pharmaceutical Ingredients
(API’s) & Quality Control

• Active Pharmaceutical Ingredients
(APIs) are produced internally, or
sourced from international suppliers.
• API tested for quality and
consistency prior to formulation.
• Assess quality control and
manufacturing practices of supplier

01

Securing Active
Pharmaceutical Ingredients
(API’s) & Quality Control

• Active Pharmaceutical Ingredients (APIs) are produced internally, or sourced from international suppliers.

• API tested for quality and
consistency prior to formulation.

• Assess quality control and
manufacturing practices of supplier

Formula
Development

• Originator product is reverse engineered for composition of active and non-active ingredients.

• Various formulations of active and non-active ingredients.

• Develop quality control matrix for formulation integrated into manufacturing.

02

Formula
Development

• Originator product is reverse engineered for composition of active and non-active ingredients.

• Various formulations of active and non-active ingredients.

• Develop quality control matrix for formulation integrated into manufacturing.

03

Manufacturing and
Production Testing

• Analysis of manufacturing complexity and requirements.

• Equipment designed and/or purchased for dedicated production line.

• Quality control matrix developed, tested for full manufacturing.

03

Manufacturing and
Production Testing

• Analysis of manufacturing complexity and requirements.

• Equipment designed and/or purchased for dedicated production line.

• Quality control matrix developed, tested for full manufacturing.

Bioequivalence Studies
And Clinical Trials

• Bioequivalency studies undertaken to measure the rate and the extent of absorption of generic drug. Results compared to originator drug.

• Comparative study submitted to Health Canada.

04

Bioequivalence Studies
And Clinical Trials

• Bioequivalency studies undertaken to measure the rate and the extent of absorption of generic drug. Results compared to originator drug.

• Comparative study submitted to Health Canada.

05

Regulatory and
Legal Challenges

• Under Patented Medicines (Notice of Compliance) Regulations a generic manufacturer is required to serve Notice of Allegation on the brand name manufacturer, claiming generic drug will not infringe any relevant patents..

05

Regulatory and
Legal Challenges

• Under Patented Medicines (Notice of Compliance) Regulations a generic manufacturer is required to serve Notice of Allegation on the brand name manufacturer, claiming generic drug will not infringe any relevant patents.

• Brand-name manufacturer can apply for an order prohibiting Health Canada from approving generic drug.
 

Provincial / Territorial
Drug Plan Listings

• Once Health Canada has issued a Notice of Compliance (NOC) and approved the drug for sale, it can be sold anywhere in Canada.

• To be reimbursed under provincial drug programs and obtain significant sales volumes, the generic drug must be listed on provincial drug benefit plans and be “interchangeable” with originator.

06

Provincial / Territorial
Drug Plan Listings

• Once Health Canada has issued a Notice of Compliance (NOC) and approved the drug for sale, it can be sold anywhere in Canada.

• To be reimbursed under provincial drug programs and obtain significant sales volumes, the generic drug must be listed on provincial drug benefit plans and be “interchangeable” with originator.

07

Patient Journey

• Patient Support Programs

• Access and Education

07

Patient Journey

• Patient Support Programs

• Access and Education