In Brief: International Policies on the Appropriate Use of Biosimilar Drugs

Key Messages

• Several countries encourage the use of biosimilars in treatment-naive patients and encourage physician-led switching to a biosimilar for those already receiving treatment with a reference biologic.
• Various countries have established different pricing, procurement, and pharmacy policies for biosimilars.
• Incentives to encourage health care providers to prescribe biosimilars have been established in some countries.
• Initiatives to increase the awareness and promote the use and access of biosimilars have been implemented in many countries in various formats, at both national and organizational levels.
• No pre- or post-market policies specific to oncology biosimilars were identified.

Introduction

Biologics are large, complex drug molecules that come from the metabolism of living organisms or their cells. Biosimilars are based on a reference biologic and are highly similar but not exact copies. Biosimilars enter the market once the pre-existing biologic’s patent has expired. They are considered cost-saving alternatives to highcost biologics for the treatment of various medical conditions. For a health care system to have successful uptake of biosimilars, many factors need to be considered, such as the number and timing of entrants into the market, patient and health care providers’ understanding and acceptance of biosimilars versus biologics, the cost of biosimilars, pricing policies, payer coverage and utilization policies, and policies regarding interchangeability and substitution. To help inform Canadian policy development, Canada's Drug Agency explored existing international post-market policies pertaining to these factors in the Environmental Scan International Policies on the Appropriate Use of Biosimilar Drugs.

What Canada's Drug Agency looked at:

• post-market policies, programs, or other strategies that have been established internationally to guide the adoption of biosimilars and to promote their appropriate and cost-effective use
• whether biosimilars used for the treatment of cancer (e.g., bevacizumab, trastuzumab, rituximab) were associated with different pre- and post-market policies internationally compared with other biosimilars.

Where Canada's Drug Agency looked for information:

• in published and grey literature, and through Internet searches
• in countries limited to the US, Australia, New Zealand, Finland, France, Germany, the Netherlands, Norway, and the UK

Table 1: Policies Related to Interchangeability, Switching, and Substitution

^a “A-flag” biosimilars are interchangeable with the reference biologic. Biosimilars for etanercept (Brenzys), infliximab (Inflectra), and adalimumab (Amgevita and Bioepis)have received “a-flag” designation, and can be automatically substituted.

^b Germany publishes a list of biosimilars known as “bioidenticals” that can be substituted at the pharmacy. “Bioidenticals” refer to only those biosimilars to a reference biologic that are manufactured by the same manufacturer, under the same manufacturing process, but sold under different trade names.

^c As of September 2018, no biosimilars have been approved by the FDA as interchangeable.

Table 2: Summary of Supply-Side Policies (Policies Implemented by Payers, and Policies Related to Pricing and Procurement)

^a Pharmaceutical Price Regulation Scheme rules set price ceilings based on negotiations and manufacturer profit levels.

Table 3: Summary of Prescribing Incentives

Table 4: Summary of Education Initiatives

^a European Medicines Agency