Safe Biologics

ASBM and Patient Groups Support WHO BQ Proposal
 

In July, the World Health Organization’s (WHO) Programme on International Nonproprietary Names (INN) released their draft Biological Qualifier (BQ) proposal that would assign a four-letter alphabetic code at random to a biological active substance manufactured at a specific site. The WHO proposal outlined 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.

In advance of the WHO’s 59^th International Nonproprietary Naming Stakeholders Session in Geneva, ASBM and 14 of its member groups, submitted comments supporting the INN BQ proposal, applauding such a significant step towards creating a naming system that prioritizes patient safety. ASBM Chairman Gewanter will be presenting at the at the Geneva meeting next week.

ASBM members who submitted comments include the American Autoimmune Related Diseases Association, International Cancer Advocacy Network, Global Healthy Living Foundation, Kidney Cancer Association, Global Colon Cancer Association, Alliance for Patient Access, American Academy of Dermatology, Zero – the End of Prostate Cancer, National Hispanic Medical Association, National Psoriasis Foundation, Health HIV, American Association for People with Disabilities, Colon Cancer Alliance and RetireSafe. 

Read the ASBM comments here.

ASBM and Over 70 Patient Groups Submit Comments to FDA 

ASBM, along with dozens of patient organizations, wrote a letter to U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg to encourage the FDA to adopt a policy of distinguishable nonproprietary names for biosimilars and to issue guidance reflecting distinguishable naming.

The letter urges the FDA to promptly address the issue of naming as it has recently accepted the first application for a biosimilar.  The letter states: 

“We firmly believe distinguishable nonproprietary names further ensure proper pharmacovigilance, as products will be clearly identified. Robust record keeping and tracking is critically important to patient safety for biosimilar and biologic medicines and holds manufactures responsible for their products. Without distinguishable nonproprietary names, pooling of adverse events, misattribution, and other difficulties are likely to occur and thus make it difficult to accurately associate a patient reaction with a particular product.”

Read the full letter here.  

ASBM in Brazil

In August, ASBM had two opportunities to participate in meetings on biosimilars in Rio de Janeiro, Brazil. 

Chairman Gewanter was a guest speaker at the August 13 “4th Latin America Forum on Biosimilars” where he gave a presentation on interchangeability. He spoke about the importance of everyone involved in the care of a patient receiving a biologic medicine needing to communicate and collaborate in the manufacturing, distribution and use of the highly complex medicines.

View his presentation here.

Ten days later, ASBM was again able to discuss international issues surrounding patient safety for biosimilars. On August 23, Global Colon Cancer Association Executive Director Andy Spiegel participated in the International Alliance of Patients’ Organizations (IAPO) “Increasing the Patient Voice in Drug Regulatory Authorities” meeting in Rio de Janeiro and then presented at the “Pre-International Conference of Drug Regulatory Authorities” on August 24. 

In his presentation, Spiegel discussed the need for unique names and urged support for the WHO BQ proposal as it will help develop a consistent, international regulatory framework for naming and help extend its protections to all of the world’s patients, regardless of the country they live in.  

View his presentation here.

ACRO Featured in BioPharma

On September 17, BioPharma published an article on the importance of clinical research organizations in the development of biosimilars. The piece pointed out that clinical research organizations – many of which are ACRO members – were involved in the development of 85 of the 88 new drugs approved by US and EU regulators last year!

Read “Fastest Way to Biosimilar Approval? As the CRO flies” here.

Purple Book

The FDA recently released the Purple Book, a listing of biologics that may serve as reference products for biosimilars. Similar to the FDA’s Orange Book, which is published for small-molecule drug substitution, the Purple Book will be published as a biologic equivalent that can serve as a tool for regulators, physicians and pharmacists when it comes to interchangeability. It lists the 104 biologics approved by the FDA and also the 276 biologic products, including vaccines, approved by the biologics center. The lists will be updated periodically as new biologics and follow-ons are approved.

Read BioWorld’s “Purple will be the new orange for biosimilar makers“

In the States…

Idaho

Pennsylvania

With only two session days left for this year, the Pennsylvania House of Representatives may consider the Senate-passed biosimilar substitution legislation SB 405 next week.  However, legislators have filed close to 40 amendments (many from the opposition) which could make passing the bill very difficult with only two days remaining and so many amendments to debate. On October 1, the House Health Committee voted 23-2 to approve the bill with an amendment that maintains the critical pharmacist-prescriber communication language that we support with a 5 year sunset provision. It is more important than ever for patient groups to weign in in Pennsylvania.

View the legislation here.

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.