Who We Are
The Alliance for Safe Biologic Medicines is an organization 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 the Alliance to serve as an authoritative resource center of information for the public, medical community, the FDA and other state and federal policymakers during the implementation of the biosimilars approval pathway and beyond.
Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis and other debilitating diseases. In November 2010 the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars. As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority.
WHO’s Minutes Reflect INN Consideration of Separate Process for ‘Biologic Qualifiers’ for Biosimilars
As reported in Inside Health Policy’s “WHO Mulls ‘Biological Qualifier,’ Separate from INN, For Biosimilars,” minutes from the meeting held this past October in Geneva reflect the serious examination by World Health Organization to create a system for unique names.
ASBM chairman Richard Dolinar, MD and executive director Michael Reilly, were present at the October meeting. Dolinar gave formal comments during the stakeholder session advocating for a system requiring unique names. However, minutes also reflect that the European Medicines Agency stated, “it was ‘unlikely’ that a biological qualifier would be used in the European Union.”
“The April meeting is going to be really interesting,” state Michael Reilly in the January 31st article, who also noted that “WHO appears to be finding a compromise among the different positions on biosimilar naming.”
FTC Biosimilars Workshop
On February 4th, the Federal Trade Commission (FTC) held “Follow-On Biosimilars Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition,” in Washington, DC.
The workshop was rescheduled from its original date of December 10th due to inclement weather. The all day workshop focused on a host of issues including the impact state regulations may have on competition; how regulations could be structured to facilitate competition as well as safety; how naming may affect competition, and experiences in other countries. Unfortunately, no patient advocacy groups were scheduled to appear. However, many ASBM partners were in attendance.
The FTC will be accepting public comments through March 1, 2014. ASBM, as well as several other members, intend to submit formal comments.
To view comments from the workshop click here.
To view patient group release and letter to FTC click here.
States Consider Substitution Legislation Early in 2014
Language introduced in WA and IN may reflect a change to come in biosimilar substitution legislation under debate in several states as some generic companies indicate they will support state proposals.
In the Washington State Legislature, biosimilars legislation — HB 2326 and SB 6091– have been introduced. Language in the legislation reflects ASBM principles, including provisions that authorize biosimilars be substituted in place of biologic products if the Food and Drug Administration (FDA) has determined the biosimilar product is interchangeable with the biologic product, and requires the dispensing pharmacist to record the name of the product and the manufacturer in a health records system that is shared with the prescribing provider or communicate it to the prescribing provider directly. It also requires the patient to be made aware of the substitution.
Both the House Health Care & Wellness Committee, and the Senate Health Care Committee have considered the legislation. Currently, the House Health Care & Wellness Committee has HB 2326 scheduled for executive session on February 5th.
To view legislation click here.
In Indiana, Senate Bill 262, which is similar to language in WA, has successfully moved out of the Senate Health & Provider Services Committee and was passed out of the full Senate on January 28th by a vote of 38 to 11. The legislation has now moved over to the House where it is hoped to quickly be considered.
To view legislation click here.
IfPA Publishes Paper on Physician’s Perspective on Biologics
The Institute for Patient Access (IfPA) recently published a paper discussing the need for doctors to be notified of automatic substutions of biosimilar products — a debate currently under consideration in the States.
In the article, Dr. David Charles and Mary Ann Chapman, PhD promote the relationships doctors must maintain with their patients in order to optimize patient care and outcomes. Since biologics are not like chemically synthesized drugs and have large, complex structures difficult to characterize and therefore are not like generics, physicians need to be informed of substitutions that may take place at the pharmacy. Without notification, practitioners may not be able to trace any adverse events or lose critical time properly diagnosing any decline in patient health.
Read IfPA 3-pager here.
Dr. Dolinar to Give Keynote at Philadelphia Conference
ASBM chairman, Richard Dolinar, MD will give the keynote address at the Biosimilars and Follow-On Biologics 2014 Americas conference in Philadelphia, February 10-12.
The conference will focus on commercial opportunities and regulatory challenges in the biosimilars arena. Dr. Dolinar’s presentation will give a practitioner’s perspective and focus on the need for physician education on biosimilars and the importance of collaboration between physicians and pharmacists to ensure the quality of patient care.
For more details on the conference, click here.
The CBI 9th Annual Biosimilars Summit, March 19th-20th – Philadelphia, PA
12 EGA International Biosimilar Medicines Conference, April 3rd-4th -London, UK
Biosimilars and Biobetters USA Conference, April 7th-8th – Iselin, NJ
2014 FDLI Annual Conference, April 23rd -24th, Washington, DC