Who We Are
The Alliance for Safe Biologic Medicines is an organization composed of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines, and others who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of ASBM to serve as an authoritative resource center for policy makers, the healthcare community and the general public on the issues surrounding biologic medications around the globe.
Our Perspective
Biologics are highly complex, advanced prescription medicines used to treat cancer, rheumatoid arthritis, diabetes, MS and many other debilitating diseases. Therefore, ASBM believes that the laws governing their approval and regulation must address that scientific reality in order to ensure patient safety. We advocate, internationally as well as in the U.S., for policies that keep medical decisions between patients and physicians; seek solutions that ensure affordability and accessibility of biologic medicines; and avoid confusion while never compromising on patient safety.
For media inquiries please contact: media@safebiologics.org
Alliance for Safe Biologic Medicines
PO Box 3691
Arlington, VA 22203
(703) 960-0601
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ASBM Submits Comments in Canadian Biosimilar Stakeholder Consultation Period
On January 13th, the third and final phase of a stakeholder consultation on Canadian biosimilar policy closed. The consultation was conducted by the Canadian Agency for Drugs and Technologies and Health (CADTH), in conjunction with the pan-Canadian Pharmaceutical Alliance (pCPA) to develop recommendations for the use and implementation of biosimilars.
The first phase of the consultation included interviews with stakeholders; the second phase was an in-person consultation on November 18, 2019, and the third and final phase was an online survey, which closed on January 13, 2020.
ASBM submitted comments with other Canadian stakeholders in the patient and physician communities who are concerned with Canadian biosimilar policy. Michael Reilly, executive director of ASBM, summarized the group’s position:
Biosimilars can be a valuable tool in controlling health costs, but it is critical that treatment decisions continue to be made by patients and their physicians, not by politicians. This is particularly true in the case of patients who are well-treated and stable on their current medications.
Moreover, the economic benefits of biosimilars need not come at the cost of patients receiving the medicine their physician chooses to best meet their needs. European countries, for example, enjoy a robust and competitive biosimilars market, with significant savings.
Nearly every country in Europe will reimburse whichever biologic the physician prescribes – whether it’s an originator biologic or a biosimilar. No European country has a forced-substitution policy enacted by government fiat (as recently seen in British Columbia and Alberta.) We urge Canadian provinces to pattern their substitution practices on the patient-friendly, physician-centered, and pro-competition policies that have proven so successful in Europe.
Read more about the consultation process here: https://www.biosimilarsconsultation.ca/the-process.
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FDA Highlights Biosimilar Approvals in 2019 Annual Report
In early January, The FDA’s Center for Drug Evaluation and Research’s (CDER) released its annual report, “Advancing Health Through Innovation: New Drug Therapy Approvals,” The report covers CDER’s notable new drug approvals and illustrates the Center’s role in bringing innovative new drug therapies that are safe and effective to patients in need.
CDER approved 48 novel medicines and 10 biosimilars during 2019, according to the report. Janet Woodcock, MD, director of CDER, praised the FDA’s success in biosimilar approvals, saying:
“Biosimilars have great potential for both patients and the entire health care system. As patents and exclusivity protections for biologics expire in the United States, we can expect many more biosimilars to be submitted for approval. More products on the market means greater competition that can lead to increased access to therapies and lower costs to patients.”
SInce its first approval in March 2015, the FDA has approved 26 biosimilars. The most recent approval, in December 2019, was for Avsola (infliximab-azzq), the fourth biosimilar for Remicade (infliximab).
Read the CDER Annual Report here.
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Patient Advocates, Opposition Party Criticize Alberta Government’s Forced-Switch Policy
On January 15th, a dozen patient advocates gathered at the Alberta Federal Building to urge the government of Alberta to halt implementation of a controversial forced-biosimilar-substitution policy announced December 12th. Adult patients, except pregnant women, currently taking a biologic drug that has a biosimilar version for their medical condition must switch to the biosimilar drug before July 1, 2020. This mirrors a policy recently enacted in British Columbia which has drawn criticism from the Canadian Association of Gastrenterology and numerous patient organizations.
One patient expressed how she was “shocked and appalled that this government is taking the decision away from physicians and patients, where it belongs”.
The patients were joined by Alberta’s NDP opposition health critic David Sheperd, who called on the government to reverse a policy he characterized as having been “botched” and which creates “a real risk for some of these folks of returning to be sick and incapacitated”.
“It’s important to introduce biosimilars (to new patients),” Sheperd said. “I recognize that there are indeed costs that we need to reckon with and I think it’s reasonable for government to move forward.
“My disagreement is with the manner in which it is moving forward: chaotic, rushed, not thought through, not considering long-term potential consequences.”
Read more here. |
| WHO Publishes Executive Summary of 69th INN Consultation
The World Health Organization recently published the Executive Summary of the 69th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances, which took place on October 22nd, 2019 in Geneva, Switzerland.
ASBM participated in the Consultation, and was represented by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. This was the thirteenth INN Consultation at which ASBM has presented.
Since 2013, ASBM has worked extensively on the issue of international harmonization of biologic nomenclature, most recently by hosting a series of meetings on this topic 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 2019.
The INN Committee’s Executive Summary of the Open Session for Stakeholders reflected several of the key points made in ASBM’s presentation, including:
- A great majority of US physicians already support the FDA 4-letter suffix with most of them also supporting the decision not to apply the suffix retrospectively.
- ASBM also reported that at the DIA annual meeting in June 2019, an FDA representative identified enhancement of pharmacovigilance and safe use as major factors in implementing their suffix, alongside the inconsistent use of other identifiers such as the National Drug Code (NDC) number.
- Even in the EU, adverse event reporting data shows that a need remains for a specific non-proprietary biologics identifier, such as the BQ, despite reporting by brand name being required by law.
- [ASBM] felt strongly that if WHO had moved to introduce the BQ many member states would have adopted it by now.
- [ASBM] felt that broad support for the BQ remains amongst regulators and prescribers and urged the WHO to act now and adopt the BQ.
Read the complete Executive Summary here.
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| UPCOMING EVENTS
LIU-Pharmacy CE Course
Queens, NY – February 23, 2020
Festival of Biologics USA
San Diego, CA – March 2-4, 2020
DIA European Meeting 2020
Brussels, Belgium – March 17-19, 2020
DIA European Meeting 2020
Brussels, Belgium – March 17-19, 2020
WHO 70th INN Consultation
Geneva, Switzerland – April 21, 2020
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