Safe Biologics

FDA Hosts Public Hearing on Biosimilars  

On January 7, ASBM members Global Colon Cancer Association (GCCA), Global Healthy Living Foundation (GHLF) and the Alliance for Patient Access (AfPA) all testified at the FDA’s Oncologic Drugs Advisory Committee (ODAC) public hearing on biosimilars. The patient groups expressed support for the pending approval, but also outlined what was needed to continue to grow patients’ confidence in the biosimilars program.

In his testimony, Andrew Spiegel, GCCA executive director and ASBM Steering Committee member, said:

“Fundamentally, patients want to know that we can expect the same safety, purity, quality and efficacy from an FDA-approved biosimilar that we can from its FDA-approved reference biologic. That level of confidence can only come through data which demonstrates therapeutic equivalence over time. That means observing the effects of these medicines in larger populations, through clinical trials and post-market surveillance.”

Read his full testimony here. 

ASBM Quoted in FDA Week on Biosimilars Meeting
 

ASBM Executive Director Michael Reilly was interviewed by FDA Week prior to the ODAC meeting on how the meeting was an important opportunity for the FDA to hear from stakeholders.

From Biosimilar Advisory Meeting May Offer Final Platform For Naming Debate:

“The advisory hearing could serve as an important platform for FDA to hear stakeholders’ input on issues such as biosimilar naming as the agency nears its possible first biosimilar approval, said Michael Reilly, executive director of the Alliance for Safe Biologic Medicines. The first approval will reveal the agency’s thinking on biosimilar naming as well as other issues surrounding the data and tests required as part of the review process, he added.”

Read more here.

FDA Releases List of Upcoming Biosimilar Guidances for 2015 

On January 6, the FDA released its annual Guidance Agenda detailing which new and revised Draft Guidances will be issued by its Center for Drug Evaluation and Research (CDER) for 2015. Among them are four guidances pertaining to biosimilarity.  Topics covered include: what data will be allowed for demonstrating biosimilarity, labeling requirements for biosimilars and how interchangeability will be determined.

Read more here.

Physician Groups Advocate for Unique Names

The Alliance for Patient Access and other specialty physician groups wrote a letter to the FDA on the importance of giving biosimilars unique names. 

On December 26, FDA Week highlighted their position in Some Doctors Push Distinct Biosimilar Names, Breaking from AMA Stance:

“A handful of specialty physician groups are siding with the innovator biologics industry in urging FDA to adopt a biosimilar naming scheme under which products have distinguishable names, pushing back against arguments made by an American Medical Association council and generic drug makers for shared International Nonproprietary Names (INNs). The groups, like innovator companies, argue that distinct names are needed to track adverse events and to protect against improper pharmacy substitution.

“The specialty physician groups wrote to FDA Thursday (Dec. 18) that a shared name would imply interchangeability, referencing statements made by the agency in past about how INNs should not be used to ‘imply pharmacologic interchangeability of products with the same active ingredient(s).’“

Read more here.

New ASBM Canadian Survey Released at Ottawa Workshop 

On December 10, ASBM Executive Director Michael Reilly presented the results from a new Canadian Survey of physicians’ views at the Subsequent Entry Biologics in Canada: Current State of the Science workshop in Ottawa. The goal of the Canadian Physician Perspectives on Subsequent Entry Biologics (SEBs) survey is to provide empirical data to Health Canada and other regulators on the perspective of Canadian physicians regarding SEBs (biosimilars), particularly for naming. 

The survey included 427 prescribers made up of dermatologists, gastroenterologists, internists, oncologists, pulmonologists, neurologists, urologists, nephrologists, rheumatologists and endocrinologists. The physicians were from four provinces in Canada – Alberta, British Columbia, Ontario and Quebec.

Read more here.

ASBM to Offer Class on Biosimilars to Pharmacists

ASBM is organizing a CE class for pharmacists on the fundamentals of biologics that will be offered through the Long Island School of Pharmacy. The five-hour class “The Fundamentals of Biosimilars: What Every Pharmacist Will Need to Know” will help pharmacists: 

1. Discuss the basic science and manufacturing of biologic medicines.
2. List the clinical implications of the key features of biologics size, complexity, sensitivity/propensity for change that distinguish biologic medicines from chemical drugs.
3. Define biosimilars and explore how they differ from generic drugs for purposes of patient care, pharmacovigilance, and pharmacy practice.
4. Discuss key regulatory and policy considerations.

The class will be held on March 15 at the New York LaGuardia Airport Marriott.

Upcoming Conferences:

Survey Presentation at Spanish Ministry of Health

On November 25, Executive Director Michael Reilly presented the European Survey results at the “1st EuropaBio – ASEBIO Meeting on Innovation and Biological Therapies” at the Spanish Ministry of Health, Social Services and Equality in Madrid. The event was hosted by EuropaBio and the Spanish Bioindustry Association (ASEBIO) and was the first time specific Spanish responses and data were presented and compared to responses from physicians in the other countries surveyed. 

Mr. Reilly pointed out that while Spanish physicians have a better understanding of biologics and biosimilars than their European counterparts, only 28% of Spanish physicians are “very familiar” with biosimilars and almost a quarter of Spanish physicians surveyed – 23% – could not define or had not heard about biosimilars before. Additionally, physicians in Spain overwhelmingly indicated that they should have the sole authority to decide the most suitable biologic medicine for their patients with 88% agreeing that they alone should be the decision-maker.

The meeting included regulators from the Spanish Ministry of Health, physicians from Spanish oncology and rheumatology societies, representatives from a hospital pharmacist organization and patient groups.

Read the press release here.

DIA Biosimilars Conference in Berlin 

On December 2, ASBM Executive Director Michael Reilly presented results from the European Survey at the DIA Biosimilars Conference held in Berlin, Germany. The conference focused on current regulatory, scientific and market access perspectives for biosimilars. ASBM provided a physician’s perspective on biosimilars on the “Health Care Professionals’ and Patients’ Perception, Understanding and Experience of the Biosimilar Concept” panel. 

Read more here.

Dr. Gewanter Responds to Hill Op-Ed

On November 18, Dr. Gewanter responded to an Op-Ed in The Hill by Tom Schatz, president of Citizens Against Government Waste, by pointing out that biosimilars were wrongly categorized in his piece as a trade/competition issue when it is really a patient safety issue.

Dr. Gewanter wrote the following statement:

“But Mr. Schatz makes a common error in equating biologic medicines with chemical medicines.  Unlike generic copies of chemical medicines, the complexity of biologics means that an attempted copy will never be identical. A biologic produced from a different cell line can, at most, be ‘similar,’ hence the term ‘biosimilars.’ This scientific reality is why biologics cannot simply be treated as generics by regulators.  Even minor differences can create adverse impact in patients, including unwanted immune responses. How similar is ‘similar enough’ to safeguard patient safety? The Food and Drug Administration (FDA) has wisely taken its time in drafting approval criteria and other guidance to answer that question accurately.”

Read more here.

Rep. Bobby Rush Op-Ed in Huffington Post

On November 6, Rep. Bobby Rush (D-Ill.) penned an Op-Ed for the Huffington Post on his concerns for ensuring safety as biosimilars are approved in the U.S. 

In Biosimilars – Another Untold Story of the Affordable Care Act he says:

There is “an earnest debate, currently taking place both in Washington, DC and in state capitals across the country, about how laws governing pharmacy practices can be updated to expand access to these drugs. While the nuances of the legislation and rules considered in each state may vary, one underlying issue has been raised in every state discussion thus far: the need to ensure active pharmacist-prescriber communications when it comes to dispensed biologics and biosimilars.

“Prescribing physicians need to know which biologic has been dispensed to support patient care in the event that a patient has an adverse response and has received multiple biologics. This is relevant not only to retail dispensed biological products, where a pharmacist and physician may not normally communicate about the history of a patient’s medicines, but also to mail-order prescriptions where the occurrence of pharmacist and prescriber communication is even less likely to take place.”

Read more here.

GaBI Newsletter Features ASBM WHO Presentation 

On November 11, ASBM was highlighted in the Generics and Biosimilars Initiative (GaBI) newsletter for presenting on naming at the WHO 59th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances. 

From More Discussion on WHO Biological Qualifier:

“During the meeting, which took place from 14–16 October 2014, the Alliance for Safe Biologic Medicines (ASBM) gave a presentation on ‘Global biosimilar naming standards: physician (and patient) perspectives’ in support of the WHO’s draft biological qualifier (BQ) proposal.

“The WHO BQ proposal would assign a four-letter alphabetic code to all biologicals [1]. The ASBM, which represents healthcare, patient and physician groups, as well as originator biologicals companies, believes that the WHO’s BQ will prioritize patient safety. In September 2014, the ASBM and 14 of its member groups submitted comments to WHO supporting the BQ proposal because it ensures clear product identification and promotes manufacturer accountability.”

Read the article here.

EMA Revises Biosimilars Guideline

In October, the European Medicines Agency (EMA) published a revised version of its 2005 overarching biosimilars guidelines that contains new recommendations on how to bring biosimilars to market in Europe. 

Read more here.

Upcoming Conferences: