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.
Our Perspective
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.
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ASBM Presents to WHO in Geneva
On October 15, ASBM Chairman Dr. Gewanter and Executive Director Michael Reilly traveled to Geneva, Switzerland to participate in the World Health Organization’s (WHO) 59th International Nonproprietary Naming Stakeholders Session. The Geneva meeting was Dr. Gewanter’s first public appearance as ASBM Chairman, a role he assumed on September 1 following Dr. Richard Dolinar’s successful three-year term. In his presentation, “Global Biosimilar Naming Standards: Physician (and Patient) Perspectives,” Dr. Gewanter thanked the WHO for the leadership they have shown on naming and again expressed ASBM’s support for the Biologic Qualifier (BQ) proposal released in August that would assign a four-letter alphabetic code to all biologics. At the request of the WHO, the stakeholder session and the specifics of Dr. Gewanter’s presentation, are to remain confidential until the WHO holds a closed session on the BQ proposal. Read the press release here. |
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ASBM in Italy After the WHO INN meeting, ASBM Executive Director Michael Reilly traveled to Rome, Italy to participate in an event held at the Italian Ministry of Health on October 20 that was titled “Biosimilars in Clinical Practice: Does Italy Need to Act?”
In his presentation, Reilly shared the results of ASBM’s European physician survey, and focused primarily on the responses from Italian physicians. Following the presentation of survey results, there was a robust and lengthy discussion about the challenges biosimilars pose for regulators but also about the tremendous opportunities they offer patients and physicians. Attendees included representatives from the Italian Medicines Agency (AIFA), physicians from the country’s nephrology and dermatology societies, representatives from a hospital pharmacist organization, patient activists, and the Italian biotechnology trade association.
Read more here.
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Business of Biosimilars in Boston
ASBM Steering Committee members John Lewis and Andrew Spiegel participated in the “Business of Biosimilars” meeting held in Boston, October 20-22.
John Lewis moderated the “Looking at the Commercial Realities of the Biosimilar Market” panel which discussed the different challenges and pathways for biosimilar adoption, and the role of payers, regulators, physicians and patients.
Andrew Spiegel was a panelist on the “Expert Opinions: Biosimilar Policies and Adoption” which was an in-depth discussion on the policy impact adoption will have on the states, particularly around substitution and physician communication.
Read more here.
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EuropaBio Publishes New Materials on Biosimilars On October 6, EuropaBio published a new Guide and a new Position Paper on Biosimilars in Europe. Titled ”When Science Meets Policy,” the two documents were designed to provide European and national regulators, policy makers, physicians, other healthcare providers and patients with information on key issues regarding biosimilars policy and why Europe must maintain high standards for biosimilars.
Read both documents here. |
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GaBI Highlights IAPO’s Advocacy Toolkit On October 3, the Generics and Biosimilars Initiative (GaBI) published an article on IAPO’s Advocacy Toolkit on Biological and Biosimilar Medicines for Patients’ Organizations. The Toolkit, which was published in November 2013, provides up-to-date, evidence-based information on the science, technology and regulatory information relevant to biologicals and biosimilars.
From “IAPO Releases Toolkit for Biologicals and Biosimilars:”
“The document follows an online consultation with IAPO members to understand the level of awareness of biologicals and biosimilars, their regulation and use, and the issues and concerns that patients’ organizations found most important. Raising patient awareness is essential, since the acceptance of generics substitution worldwide has been slow, with research showing that many patients get confused or feel apprehensive about having their drugs changed [1].Topics covered in the toolkit include the safety of biologicals, how they are regulated and monitored, how they are prescribed and dispensed, who can access them and what information and support is available to patients.”
Read the article here. |
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In the States…
Idaho The Idaho Board of Pharmacy adopted the draft biosimilars rule on October 23, that did not include physician communication. The recommendation will go into effect unless two-thirds of the legislature overrides it or enacts independent legislation.
Pennsylvania The Pennsylvania House of Representatives did not consider the Senate-passed biosimilar substitution legislation SB 405 before adjourning for the session.
Many states have finished their legislative sessions for the year, but ASBM will continue to educate lawmakers and work to ensure patient safety is the main priority as biosimilar policies are created across the country.
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Are You Following ASBM on Social Media?
For the latest ASBM activities and updates make sure you are following us via social media:
Twitter: @SafeBiologics Facebook: https://www.facebook.com/SafeBiologicMedicines LinkedIn: http://linkd.in/1zhVaCk YouTube: https://www.youtube.com/channel/UCq9XO-27MVdPcZQcHs6_0vA
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Upcoming Conferences:
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