As of February, two Canadian provinces, British Columbia and Alberta, have implemented or partially implemented forced biosimilar non-medical switching policies. The controversial policies drew strong objections from many in the GI patient and physician community.

In a 2017 survey, more than 2/3 of Canadian physicians surveyed said they were not comfortable with a third-party switching their patient to a biosimilar for non-medical reasons (i.e., coverage), as occurs under the BC and Alberta policies. 83% considered it “very important” or “critical” that the prescribing physician decide the most suitable biologic for their patients.

Full implementation of the Alberta policy was delayed six months as a result of the COVID-19 pandemic. Other provinces including Ontario and Quebec are still considering whether or not to enact similar policies.

Quebec’s National Institute of Excellence in Health and Social Services (INESS) recently released the official English translation of its report “Safety of switching biologics and their interchangeability”. The report found:

There is very little clinician opposition to the use of biosimilars in treatment-naive patients…the picture is different and much more nuanced regarding the use of biosimilars in individuals who are already being treated with a reference biologic drug, in particular because of the risks of immunogenicity posed by the use of biologic drugs and the possible loss of efficacy.

In this respect, all the learned societies are clearly opposed to non-medical switching of a biologic drug, and instead favour medical switching, by which the decision to switch a patient’s treatment rests with the individual and his or her doctor. This position is shared by all the clinicians consulted for this project, who stress that the physician is the best person to assess the risk of treatment switching in a given patient.

The INESSS report also contrasts BC- and Alberta- style forced-substitution policies with those of Western Europe, likening it more to those in Eastern Europe:

“Most of the jurisdictions examined are in favour of switching patients being treated with a reference biologic drug to a biosimilar, but do not impose this on all patients (via financial penalties or incentives, quotas, etc.)… Only a few European countries (Denmark, Bulgaria, Poland and Serbia) and two Canadian provinces have adopted policies for mandatory non-medical switching for the vast majority of patients (national tendering processes or reimbursement of biosimilars only).”

The pro-competition, pro-physician choice policies found in most European biosimilar markets were the subject of a recent whitepaper by ASBM’s Michael Reilly and Philip Schneider; read that paper here. 

Also new for 2021, ASBM Member the Gastrointestinal Society has released a series of resources for Canadian patients, including a handout entitled “Good Biosimilars Policy in Canada 2021” which reflects principles of biosimilar substitution policy supported by GI patient advocacy organizations. From the document:
Biosimilar policies should not force patients who are currently stable on their medications to switch to another medication for no medical reason, called non-medical switching (NMS). It is unnecessary to force chronic disease patients to switch to a biosimilar when the patent expires on an originator biologic they are currently taking. In fact, scientific evidence does not support NMS.

The Gastrointestinal Society also has a list of recommended exemptions  were a province to implement such a policy. These include, pregnant women, the elderly, high-risk patients, those with severe disease, and children.

Learn more about forced biosimilar substitution policies in Canada at NoForcedSwitching.ca.

From March 29-April 1st, ASBM will be participating in the Festival of Biologics USA, part of the World Biosimilar Congress USA 2021. The event is typically held in San Diego, CA but will be held virtually this year due to travel restrictions related to the COVID-19 pandemic.

At the event, ASBM Steering Committee Member Andrew Spiegel will moderate two panels. The first will be a keynote panel discussion entitled “Biosimilar Regulatory Reform” on March 29th.

The second will be a plenary keynote panel discussion “Biosimilar Uptake and Progress from the Healthcare Perspective”, on March 31st.

In addition, on March 31st, ASBM Advisory Board Chair Philip Schneider will moderate the closing keynote panel discussion panel: “Harnessing influence to change biosimilar policies: current programs and ideas for the future” 
Learn more about the Festival of Biologics and view the program agendahere. 

Biosimilar use among Medicare fee-for-service beneficiaries seems to depend most on practice setting and hospital ownership status, with few patient or physician characteristics linked to usage, according to data in JAMA Open Network, reports Healio Rheumatology.

However, the types of practices — outpatient hospital department versus office — and hospital ownership status — for-profit versus not-for-profit — with high biosimilar use appeared to differ vastly based on drug class, noted the researchers.

For example, patients in a hospital outpatient setting were 42% less likely to receive a filgrastim (Neupogen, Amgen) biosimilar than those in an office setting, but 73% more likely to receive an infliximab (Remicade, Janssen) biosimilar.
“For a number of reasons, physicians treating chronic diseases might be less willing to switch patients who are controlled on an originator biologic, such as Remicade, to a biosimilar equivalent,” coauthor Emma Boswell Dean, PhD, of the Miami Business School at the University of Miami, told Healio Rheumatology.

Read the full article here. 

The development of a standardized approach for evaluating and implementing biosimilar products improves efficiency and collaboration, including in clinical research; according to an article appearing in the February issue of the American Journal of Healthsystem Pharmacy.

This article describes the initial approach to evaluating and implementing biosimilar agents at a comprehensive cancer center in Houston, TX, with a focus on strategies, challenges, lessons learned, and ongoing considerations. It also highlights practical considerations and may serve as a guide to other institutions as they navigate the biosimilar landscape and develop their own processes to support the transition to biosimilars in practice.

Implementing biosimilars for agents used to treat cancer will pose new challenges and require additional considerations. Partial implementation of biosimilars continues to pose multiple challenges in the provision of patient care.

Key points of the analysis:

• Collaboration of pharmacy and pharmacy informatics personnel is essential in identifying and implementing optimal ordering tools when transitioning to biosimilar products.
• Biosimilar adoption may have implications on research protocols, including the consenting process and the need for protocol amendments, requiring institutional review board oversight and, potentially, rolling implementation.
• Institutions may be required to stock the reference product and biosimilar product(s) during the transition period (or beyond due to conflicting payer policies) and should develop processes to oversee inventory and minimize the risk of errors.

The University of Texas MD Anderson Cancer Center is one of the 50 National Cancer Institute–designated comprehensive cancer centers and was created in 1941 as part of the University of Texas System. In fiscal year 2018, MD Anderson provided care to more than 140,000 patients, including over 10,000 patients enrolled in over 1,250 clinical trials.

Read the full article here. 

(These concerns were echoed by physicians in ASBM’s recent survey of 579 European biologic prescribers, 63% of whom considered it “very important” or “critical” for government tenders for a biosimilar to include multiple suppliers.)

The lower costs that biosimilars offer—approaching 50% in some cases—are enticing. “However, there are several important observations that must be considered which make biosimilar products less than the universal panacea they were hypothesized during their inception,” the NCCN guideline said.
Payers have a large role in the choice of biosimilars, and this was the top-rated concern among those who took the survey. Making the electronic health record work to identify coverage for biosimilars was the second highest-rated concern, followed by the challenges of obtaining payer authorization for biosimilars. Actual procurement of biosimilars and effective storage of multiple biologics also were high-ranking concerns.
“One strategy is to stock multiple biosimilar products…. However, this strategy may increase carrying costs and place a strain on storage requirements such as refrigerators,” the NCCN said. Dispensing errors may increase if staffers grab the wrong product off the shelves.

Read the full NCCN Pharmacy Directors report here.

Read a summary of the report here.

Since biosimilars first entered the Canadian market in 2009, uptake has been slow in comparison to other OECD countries, with only 18 biosimilars approved to date, and none within ophthalmology, as detailed in a new report from the International Foundation on Ageing (IFA).

Safety, efficacy, and the appropriate use of biosimilars are concerns that impact the lives of patients and their families as well as prescribing physicians. However, there is currently a gap in resources that respond to these concerns internationally and within Canada.

Toward enabling informed decision-making between older Canadians, their caregivers and health care professionals, this report explores the urgent need to build an educational framework. From the report:

Biosimilars in ophthalmology in Canada are on the horizon. Now is the time to strategically plan and act to ensure the education requirements of health care professionals, patients and their families are firmly in place and inform policy development, and not lag behind.

Framed around the goal of enabling informed consultations and decision-making between patients and health care professionals, international biosimilar experiences and to a lesser extent those in Canada provide evidence-based guidance and insight to build an educational framework that serves to inform the debate options on policy and practice.

Read the full report here. 

Missed last month’s ASBM Newsletter? Read it Here.

World Biosimilar Congress USA 2021

Virtual – March 29-31, 2021

WHO 72nd INN Consultation

Geneva, Switzerland/Virtual – April 13, 2021

Biologics Europe Online (Webinar)

Virtual – April 26-27, 2021

DIA Global 2020 Annual Meeting

Philadelphia, PA – June 27- July 1, 2020