Safe Biologics

ASBM Announces New Chairman and IAB Chair

The Alliance for Safe Biologic Medicines (ASBM) recently announced pediatric rheumatologist and current ASBM International Advisory Board (IAB) member, Harry L. Gewanter, MD, FAAP, FACR as ASBM’s incoming chairman. Dr. Gewanter succeeds outgoing chairman Richard Dolinar, MD, who served as ASBM’s initial chairman since 2011.

In addition, Philip Schneider, MS, FASHP, Professor and Associate Dean at the University of Arizona, College of Pharmacy will serve as the International Advisory Board Chair.  Dr. Schneider has served on the ASBM advisory board since September 2012.

“Dr. Dolinar has been an outstanding leader in the education of physicians, patients and policymakers alike in the relatively new arena of biologics and biosimilars,” stated Michael Reilly, Executive Director of ASBM. “With Dr. Dolinar as chairman, our membership and impact has grown and we appreciate his guidance. We now welcome Dr. Gewanter and Dr. Schneider to take leadership positions within ASBM to showcase the role both physicians and pharmacists play in working on biosimilars issues.”

Gewanter and Schneider assume their positions on September 1st.

Read ASBM press release here. 

WHO INN Programme Releases Draft BQ Proposal

In July, the World Health Organization’s (WHO) Programme on International Nonproprietary Names (INN) released their draft Biological Qualifier (BQ) proposal — a four-letter alphabetic code assigned at random to a biological active substance manufactured at a specific site.  In the document, the WHO outlines a plan for the use of BQ’s as a way to resolve the nomenclature issues worldwide, ensuring clear product identification and promoting manufacturer accountability.

While not formally part of the product’s INN, the BQ would be used on all biologic active substances to which INNs are assigned and administered by the INN Secretariat. Participation in the BQ system by national regulatory authorities (NRAs) will be voluntary, but all NRAs will have access to the manufacturing location and regulatory history for any product assigned a BQ.

In its executive summary, the WHO INN states: 

“Where the use of a BQ is considered by an authority to be desirable the availability of a single global scheme will avoid proliferation of separate and distinct national qualifier systems.“

The draft was prepared in order to solicit comments to the proposal which will then be considered by the INN Expert Group. Written comments into the WHO must be received by September 19th. 

To read the BQ proposal, click here. 

FDA Releases Guidance on Biologic Exclusivity

Reference biologics meeting certain criteria may qualify for a 12-year period of exclusivity, according to new guidance issued by the Food and Drug Administration (FDA) on August 4th.

In order to qualify, proposed biologics based upon a previously licensed biologic must demonstrate that any structural modifications result in increased safety, purity, or potency. Biologics are statutorily prohibited by the Biologics Price Competition and Innovation Act of 2009 (BPCIA) from receiving the 12-year period of exclusivity when changes from a previously licensed biologic result merely in a new indication, route of administration, or dosing schedule.

“In cases where FDA determines that a proposed biological product includes a modification to the structure of a previously licensed biological product, FDA generally will presume that the modification has resulted in a change to the proposed product’s safety, purity, or potency if the sponsor of the proposed product demonstrates that it affects a different molecular target than the original product”, according to the guidance, which may be read in full here.

First Biosimilar Application Received by FDA

The U.S. Food and Drug Administration (FDA) recently received its first application for a biosimilar under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The biosimilar Filgrastim, manufactured by Sandoz and currently marketed in 33 countries as ZARZIO, is similar to the innovator product NEUPOGEN used to treat blood cancers. 

“Sandoz’s application is an important first step in carving out the pathway biosimilars will take in the U.S.,” stated ASBM Chairman, Richard Dolinar, MD.  “Now that the FDA has received this application, we will learn much about how the FDA will provide patients with access to biosimilars while also maintaining the world-class standards for safety of our medicines.  It is our hope that we will see the FDA make decisions on the issues they have yet to provide comment on, such as naming and interchangeability.”

To view Sandoz announcement, click here.

Senators Send Letters to HHS Seeking Further Guidance on Biosimilars

Six U.S. Senators have sent two letters to Secretary Burwell of the U.S. Department of Health and Human Services (HHS) requesting the release of FDA guidance regarding biosimilar naming policy under BPCIA.

In a letter to the Secretary on July 30th, Senator Kay Hagen (NC) wrote:

“A transparent and timely process for implementing the biosimilars pathway is essential so all stakeholders have a clear understanding of the Agency’s expectations for the review of biosimilars.”

Additionally, on August 1, the Senate Health, Education, Labor and Pension (HELP) Committee also urged HHS to move forward on several biosimilar guidances — specifically relating to naming and interchangeability. Senators Alexander (TN), Hatch (UT), Enzi (WY), Burr (NC), and Roberts (KS) wrote:

“We have heard there is some differences of opinion on these matters, making it even more important that these policies, which are integral to the success of the biosimilar pathway, be released in draft form as soon as possible.”

Both letters urge the draft guidances to be released by FDA for public comment, especially before the approval of the United States’ first biosimilar. 

Read Senator Hagan’s letter here.

Read Senate HELP Committee letter here.

European Commission Report

As a result of a multi-stakeholder project in Europe, the publication of “What you need to know about Biosimilar Medicinal Products” has recently been translated into English, French, German, Italian, Spanish and soon Portuguese. The paper was originally a result of the European Commission “Platform on Access to Medicines in Europe”.  The translation to more languages for better use amongst stakeholders was sponsored by ASBM member EuropaBIO, as well as the European Generic Association and the European Federation of Pharmaceutical Industries and Associations. 

The consensus document has been developed to provide comprehensive information on the concept of biosimilar medicinal products and includes the science, regulatory and economic aspects of these medicines.  The goal of the document is to make science and medical societies, healthcare professional, patients and their representative organizations better informed on this topic.

For publications, click here.

For more information from EuropaBIO, click here.

In the States…

Idaho

Pennsylvania

The Pennsylvania House of Representatives, Health Committee currently holds biosimilars legislation for consideration potentially this fall.  SB 405 was voted out of the Senate by a 44-6 margin on June 24th.  The legislation included provisions which outlined FDA approved ‘interchangeable’ biosimilars, and maintained the right of physicians to prohibit substitution, as well as ensured patient communication of any switches that took place at the pharmacy level. The current language also requires physician notification to occur within 72 hours of dispensing, and requires record keeping for at least two years.

Also in PA news, Mark Seraly, MD recently wrote to the Pittsburgh Post-Gazette to further educate the public on biosimilars issues and urge legislative action.  In the July 9th opinion editorial entitled, “Pennsylvania has a chance to update its law to allow for biosimilars medicines substitution,” Seraly advocates for provisions included in the current legislation and the availability of “safe and presumably lower-cost alternative.”

Seraly is in private practice and is a board-certified dermatologist with over 20 years of clinical experience. He also serves as an adjunct teaching facility for the University of Pittsburgh Department of Dermatology residence program. 

View Pittsburgh Post-Gazette op-ed here.

View legislation here.

GHLF Hosts First ‘Tweet-Up’ on Biosimilars

On July 9th, the Global Healthy Living Foundation (GHLF) hosted a ‘tweet-up’ from their twitter handle @CreakyJoints to get their advocates engaged, informed and connected with other individuals on the issue of biosimilars. 

Individuals participated in the tweet-up by following the #CreakyChats conversation, which included former FDA associate commissioner, Peter Pitts and ASBM.  The conversation with patients included everything from “what is a biosimilar? to the importance of policy measures under consideration and what that may mean for patients. 

Upcoming Conferences:

• August 13th and 14th: 4th Latin America Forum on Biosimilars, Rio de Janeiro, Brazil
• August 23rd: IAPO’s “Increasing the Patient voice in drug regulatory Authorities” meeting, Rio de Janeiro, Brazil
• August 24th and 25th:  Pre-International Conference of Drug Regulatory Authorities, Rio de Janeiro, Brazil
• September 18th and 19th: DIA Biosimilars 2014, Washington, DC
• September 20th:  European Parkinson’s Disease Association Unity Walk, Luxembourg
• October 14th: WHO 59th International Nonproprietary Naming Stakeholders Session, Geneva
• October 20th:  ASBM’s Joint Release with AIFA (Italy’s Medicine Agency) Italian Physician’s Survey, Rome, Italy.