DIA/FDA Conference on Biosimilars

September 17, 2012

On September 13, Dr. Dolinar presented on two panels at the DIA/FDA Biosimilars Conference: Guidances, Science, and BsUFA in Washington, D.C. His first panel was on Pharmacovigilance, Naming, and Labeling and the second panel was on Interchangeability.

DIA Presentation on Biosimilar Naming
DIA Presentation on Interchangeability

During the conference, ASBM released a new survey examining physician practices and perspectives with regard to biosimilars and substitution.

Results showed:

Inappropriate substitution is a major risk if different biologics have the same scientific name.

  • 64 percent of surveyed physicians assume if products have the same name a patient can be safely switched from one product to another during treatment.
  • More than 76 percent view products with the same scientific name as structurally identical.

Names are the primary means of product identification for physicians.

  • The vast majority (99 percent) of physicians refer to biologic medicines by name for both recording in charts and for reporting adverse events.
  • Less than 1 percent of prescribers use national drug code numbers for records or reporting.

Physicians are very concerned about a patient being switched from one biologic to another.

  • 85 percent of responding physicians want the authority to designate a biologic medicine as “Dispensed as Written”, just as they have it for chemical products.
  • 86 percent of physicians want to be notified BEFORE a patient is switched to a biologic other than the one prescribed EVEN IF there are no known concerns associated with the product.

View the ASBM Biosimilars Survey.

New ASBM Survey Reveals Key Safety Concern Associated with Biosimilar Naming

September 13, 2012

The Alliance for Safe Biologics released a new survey examining physician practices and perspectives with regard to biosimilar medicine identification and substitution – policy issues that remain unresolved and will have a fundamental impact on patient safety. Over 350 endocrinologists, dermatologists, oncologists, rheumatologists, nephrologists and neurologists – all specialties that prescribe biologics – responded to the survey.

View the ASBM Biosimilars Survey.

ASBM Quoted in FDA Week Story on Naming

September 7, 2012

ASBM Executive Director Michael Reilly was quoted in the FDA Week story Stakeholders Draw Biosimilar Naming Insight From Biologic Approval.

Read the article.

Dr. Dolinar Presents at Florida Association of Health Plans

September 6, 2012

On September 6, Dr. Dolinar presented an overview of biologics and biosimilars at the Florida Association of Health Plans Annual Conference.

View his FAHP Presentation

ASBM to Host Roundtables on Physician Notification

July 24, 2012

The Alliance for Safe Biologic Medicines (ASBM) will host a series of roundtables beginning in September to seek input from the patient, physician and pharmacist communities on the issue of physician notification for biosimilars.

The roundtables seek to build on the May 24th ASBM Advisory Board physician notification working group meeting led by Chairman Richard Dolinar, M.D.   The first roundtable will be held in Phoenix, Arizona where Dr. Dolinar is a practicing endocrinologist and where the International Cancer Advocacy Network (ICAN), an ASBM member, is based.

When announcing the roundtables Dolinar made it clear that any notification policy formalized by ASBM must acknowledge the unique roles of pharmacists and physicians and must ensure that they work together in the best interests of the patient.  “As a practicing physician, I know well the valuable role pharmacists play in making sure that patients receive the treatments that are best for them.  They also play a critical role helping physicians quickly trace back the source of an adverse drug event when they occur.    We are determined to bring pharmacists into the discussion so that we can put forth a thoughtful notification policy that promotes patient safety without interfering with the pharmacists’ autonomy or ability to serve their patients in a timely manner.”

Forbes: FDA Balances Costs, Patient Safety in the Biologics and Personalized Medicine

July 23, 2012

Good piece on biosimilars in Forbes by Jon Entine, Senior Fellow at the Center for Health & Risk Communication at George Mason University. Read FDA Balances Costs, Patient Safety in the Biologics and Personalized Medicine

President Obama Signs FDA User Fee Bill

July 10, 2012

On July 9, President Obama signed the bipartisan Food and Drug Administration Safety and Innovation Act, that reauthorizes FDA user fees and that will establish new user-fee programs for biosimilar drugs. Read more.

ASBM Presents in Toronto, Canada

June 28, 2012

On June 4, Alliance Chairman Dr. Richard Dolinar and Executive Director Michael Reilly presented at the Canadian Patient Experts in Health Technology forum in Toronto, Canada. The forum was organized by Durhane Wong-Rieger, president of the Canadian Organization for Rare Disorders. The two-day event was set up to establish a global network of individual patient experts and discuss pressing issues related to the access of drugs and health technology. Continue reading…

Alliance for Safe Biologic Medicines Responds to Supreme Court Decision

June 28, 2012

WASHINGTON – Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines (ASBM) issued the following statement in response to the Supreme Court ruling on the Affordable Care Act and its impact on the Food and Drug Administration’s (FDA) creation of a biosimilar pathway.

“As biosimilar medicines are introduced into the U.S. in the next few years, ASBM believes patient safety must be the top priority while the FDA creates a pathway for their approval. Because biosimilars are similar to, but not exact copies of the biologic medicines they aim to replicate, it is imperative that patient safety is the cornerstone of the approval process. Unlike traditional pharmaceutical drugs that are made from chemicals, biologics are developed from living cells, large and complex molecular mixtures that are not easily replicated.  The smallest differences in the structure or manufacturing process could have serious implications for patients.

“We have supported the initial steps the FDA has taken to create this framework and will continue to encourage the incorporation of a patient-centered, science-based approach, similar to those taken in the European Union and in Canada. We are looking forward to additional opportunities to weigh in with the FDA as it formalizes the biosimilar pathway.”

To speak to Dr. Dolinar or another member of the Alliance for Safe Biologic Medicines, please email media@safebiologics.org.

About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. We serve as an authoritative resource center of information for the public, medical communities, the FDA and other state and federal policymakers during the implementation of the biosimilars pathway and beyond.  Visit us at www.safebiologics.org.

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Alliance for Safe Biologic Medicines Responds to Supreme Court Decision

June 28, 2012

WASHINGTON – Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines (ASBM) issued the following statement in response to the Supreme Court ruling on the Affordable Care Act and its impact on the Food and Drug Administration’s (FDA) creation of a biosimilar pathway.

“As biosimilar medicines are introduced into the U.S. in the next few years, ASBM believes patient safety must be the top priority while the FDA creates a pathway for their approval. Because biosimilars are similar to, but not exact copies of the biologic medicines they aim to replicate, it is imperative that patient safety is the cornerstone of the approval process. Unlike traditional pharmaceutical drugs that are made from chemicals, biologics are developed from living cells, large and complex molecular mixtures that are not easily replicated.  The smallest differences in the structure or manufacturing process could have serious implications for patients.

“We have supported the initial steps the FDA has taken to create this framework and will continue to encourage the incorporation of a patient-centered, science-based approach, similar to those taken in the European Union and in Canada. We are looking forward to additional opportunities to weigh in with the FDA as it formalizes the biosimilar pathway.”

To speak to Dr. Dolinar or another member of the Alliance for Safe Biologic Medicines, please email media@safebiologics.org.

About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. We serve as an authoritative resource center of information for the public, medical communities, the FDA and other state and federal policymakers during the implementation of the biosimilars pathway and beyond.  Visit us at www.safebiologics.org.

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