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.