www.NoForcedSwitching.ca

This controversial practice is rare among the advanced countries of the world, and has raised concerns among patient and physician organizations worldwide. In nearly every European country, for example, patients and physicians are free to choose the most suitable product, and while new patients are encouraged to try the lowest cost medicine first, the treatment decision ultimately rests with the physician and patient. All products are reimbursed, and automatic or forced substitution is not practiced.

The microsite contains a variety of materials, including:

• National and province-specific news stories about how provinces have implemented, or are considering such policies.
• Statements from physician societies and patient advocacy organizations raising concerns with the practice
• Fact sheets contrasting the forced-substitution policies of British Columbia and Alberta with the pro-competition policies of European countries
• Surveys showing strong physician opposition to third-party non-medical substitutions from physicians in Europe and Canada
• A whitepaper showing how European countries achieve biosimilar savings by preserving- not limiting- physician and patient choice
• Shareable social media graphics
• The ability for Canadians to quickly send a message to your Health Minister expressing your opposition to forced substitution in their province

We encourage you to take a moment to visit: www.noforcedswitching.ca

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has opened a six-week consultation period on new guidanceintended to help developers of biosimilars more clearly understand the requirements for biosimilar products in the UK.

• UK reference products
• the lack of requirement for in vivo studies in animals
• the changes in the requirement for a comparative efficacy trial in most cases

Public Webinar on Final PMPRB Guidelines November 20th

Canada’s PMPRB will be hosting a public webinar to discuss its’ recently-recently-finalized drug pricing Guidelines and address questions. Originally scheduled to take place on November 10th, the webinar has been re-scheduled to November 20th, from 1:30PM to 2:30PM (EST).

The link for the webinar can be accessed from the PMPRB’s  Guidelines Home Page. No registration is required to join the webinar.

Next month, the Journal of the Generics and Biosimilars Initiative (GaBI Journal) will publish Issue 4 of its 2020 print edition. The issue will contain a whitepaper entitled “US biosimilars marketplace on pace with Europe”. The article is co-authored by ASBM’s Executive Director Michael Reilly and its Chair, Madelaine Feldman, MD, FACR.

The paper will explores in detail the considerable successes of the U.S. biosimilar pathway in its first 10 years, including the approval of 28 biosimilars and launch of 18 of these in just over five years’ time. In addition, the paper will examine how competition between multiple biosimilars are increasingly leading to lower prices and greater biosimilar market share. From the paper:

In the US, biosimilars have gained significant share in the majority of therapeutic areas in which they have been introduced, ranging on average from 20% to 25% within the first year of launch, with some projected to reach greater than 50% within the first 2 years. As expected, first-to-market biosimilars tend to capture a greater portion of the segment compared to later entrants. Filgrastim biosimilars have been on the market the longest at 5 years and have achieved a 72% share, while bevacizumab and trastuzumab biosimilars have approximately 40% share. Rituximab and infliximab have had the most limited adoption, with approximately 20% market share.

The paper may be viewed online at Gabi’s website here.  

On November 18, the Biologic Prescribers Collaborative, along with the Institute for Patient Access and the Alliance for Patient Access will co-host its fifth annual National Policy & Virtual Summit on Biologics.

The event will run 11:30 a.m. to 2 p.m. EDT, Wednesday, November 18.

Click here to register for the event.

ASBM Presents at WHO’s 71st INN Consultation 

On October 20th, ASBM presented to the World Health Organization’s (WHO’s) 71st Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the fifteenth INN Consultation at which ASBM has presented.

ASBM was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. Due to coronavirus-related travel restrictions in place at the time of the consultation, the presentation was made online.

Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings with FDA, Health Canada, and the WHO. Dr. Schneider also gave a presentation on the value of distinct biologic naming and the status of harmonization efforts at the DIA Global Annual Meeting in June.  In 2014, the WHO proposed that all biologics sharing an INN be assigned a unique four-letter suffix called a “biological qualifier” or BQ. While initially supported by many national regulatory authorities including the FDA, Health Canada, and Australia’s Therapeutic Goods Administration (TGA), the BQ proposal has not yet been implemented. In 2015 the FDA adopted its own BQ-like suffix system, and until recently was in conversations with Canada about harmonizing nomenclature systems regionally.
While the discussions in the Open Session at which ASBM presented are bound by confidentiality agreements pending the publication of an Executive Summary by the INN Programme,  the Executive Summary from the 70th INN Consultation – held on April 21, 2020 and in which ASBM also participated – may be viewed here. From the Executive Summary:

The Covid-19 pandemic highlights the leadership that WHO has in global health, and ASBM believes that this leadership is critical also for the naming of biosimilars, as it has repeatedly stated, especially as the number of biosimilars is increasing each year. It is also important to recognise that the biological qualifier (BQ) is still valid and that broad support for the BQ remains. The US FDA is supportive of unique identifiers for biologics and has instigated its own random 4-letter suffix. Health Canada (HC) has been a past supporter and is willing to harmonise, similarly the Australian TGA. The ASBM noted that many other countries including Denmark, Japan and Jordan also support the BQ, while physicians are also supportive. However, despite this support, countries have developed their own system but would have used a WHO system if WHO had moved ahead with the BQ.

ASBM surveys have consistently shown strong support for distinct naming among physicians worldwide. 66% percent of U.S. physicians surveyed support distinct naming for all biologics, including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.

Read more about ASBM’s work with the WHO’s INN Group here. 

Missed last month’s ASBM Newsletter?

Read it Here. 

DIA Latin America Pharmacovigilance and Risk Management Strategies Workshop
Virtual – Nov 11-12, 2020

National Policy & Advocacy Virtual Summit on Biologics

Virtual – November 18, 2020

Saudi Gastroenterology Association Conference

Virtual – November 22, 29, 2020