Safe Biologics

State Activity

With the start of a new year, comes the start of a new legislative calendar. The past weeks have been very busy as many states are considering substitution legislation. ASBM and our members have been sending in letters of support in CO, VA, IN and ND and will continue to express our concerns for patient safety as more legislation is introduced.

All state activity can be found on our “In the States” page on our website. You can also find our One Pager on Automatic Substitution stressing that patients and physicians want doctors involved in treatment decisions.

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Colorado

Colorado has been buzzing with the introduction of biosimilar substitution legislation House Bill 1121, which ASBM and our members have shown great support for. The CO bill was voted out of the House Health, Insurance & Environment Committee on February 12 and will be sent to the House and then the Senate for a full vote in the coming weeks. Thanks to Allen Todd with Global Healthy Living Foundation for testifying on behalf of patients before the committee.

Read his testimony here.

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Prior to the hearing, Andrew Spiegel with the Colon Cancer Alliance sent in a letter of support saying:

“If patients and their physicians do not know what medicines they are taking, they can’t make the right decisions; they deserve to know when a biologic that has been working to keep them alive is being substituted, especially until we learn more about biosimilars.

“We agree that when interchangeable biosimilar products are substituted, communication among patients, pharmacists, and health care providers is essential to patient care. Opponents of the bill suggest that its provisions are onerous and intended to prevent the substitution of biosimilars from occurring, however, the physician notification requirement does not kick in until after the substitution has occurred. Physicians and pharmacists work together on a daily basis to ensure patients receive proper care, and there is no reason why dealing with highly complex, next generation medicines should be any different.”

Read ASBM, GHLF and CCA’s letters here.

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Virginia

In Virginia, ASBM and several members sent letters of support for House Bill 1422. When the Senate version failed to adopt all of all patient protections that the House included in their bill ASBM, AfPA, CCA, GHLF, ICAN, Kidney Cancer and RetireSafe signed onto a joint letter with other patient groups urging the Senate to include provisions from the house bill.

The letter stated:

“For many of the more than two million Virginia patients—including our seniors, children and veterans—who suffer from one or more chronic illnesses, biologic medicines represent life-changing, and often lifesaving, therapies. They have improved quality of life, mitigated symptoms and reduced both disability and mortality rates.

“As important as these therapies are, it is just as important that public officials take special care to ensure the safety of the patients who rely upon them…That is why we strongly urge adoption by the Senate of all patient protections contained in House Bill 1422. This measure will bring Virginia state law in line with advances in modern medicine while also providing the essential safeguards that will ensure that Virginia patients receive exactly the medicines they need and will not be subject to potentially harmful substitutions.”

Read the full letter here.

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Advisory Board Members Weigh In

Dr. Harry Gewanter, a pediatric rheumatologist in Richmond and member of the ASBM Advisory Board, penned an Op-Ed for the Richmond Times-Dispatch and also wrote a letter to the editor to the Lynchburg News & Advance in response to VA legislation.

In his Op-Ed “Legislation would protect patients taking complex meds,” he said:

“Specifically, the legislation would permit pharmacists to dispense a biosimilar that has been licensed by the FDA as substitutable with a prescribed biologic product, unless the patient’s doctor indicates otherwise or the patient asks for the brand-name version. It also would require the pharmacist to provide timely notification of this substitution to the doctor in a manner that is not a burden upon the pharmacist…Why is this important? We already know that each person responds differently to any medication, chemical or biologic. Generic chemical medications are easier to manufacture with less variability between them. However, since biologics and biosimilars are created using living cells, using current technology they can be closely approximated, but not necessarily exactly replicated. This creates a much greater chance of differences during the creation of a biologic and its biosimilar imitations. Any slight alteration in the production process could influence the effectiveness of a biologic and create unknown or negative consequences.”

Read the Op-Ed here.

In his letter “Healing or dollars?” Dr. Gewanter points out that the Senate version of the VA bill:

“Eliminates this critical communication between pharmacists, patients and their physicians in 2015. If I do not know that my patient with juvenile arthritis is not doing well because a substitution of a medication has occurred, I may change treatments or submit this child to many other evaluations that are not necessary. Chronic illness care requires close and ongoing communication between all members of a patient’s health care team. As a physician and a parent, I believe this communication and the resultant patient safety is far more important than any theoretical monetary savings [the Senate bill] touts.”

Read the full letter to the editor here.

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Indiana and North Dakota

We have also been following the bills in both Indiana and North Dakota and have sent in letters of support, highlighting the importance of allowing substitution as long as the biosimilar has been determined by the FDA to be interchangeable with the prescribed product for the specified indicated use and that the physician is notified.

Read the letters here.

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Upcoming Conference

Dr. Dolinar will be presenting at CBI’s 8th Biosimilars Summit, on the “Assess Global Quality Standards for Biologics in Regulated and Unregulated Markets” panel on March 5 in Washington, D.C.

Read more on the conference here.

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ASBM Shows Support for VA Legislation on Interchangeability

The Virginia House of Delegates introduced legislation on interchangeable biosimilars and held a hearing on the bill, H.B.1422, on January 15. To show support of the bill, Dr. Dolinar, the Colon Cancer Alliance, Global Healthy Living Foundation and the Kidney Cancer Association sent letters to members of the House Committee on Health, Welfare and Institutions.

We expect to see legislation on substitution in many other states and will monitor and engage accordingly.

Read more here.

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Inside Health Policy Article on VA Legislation

Inside Health Policy highlighted the ASBM letters to VA delegates in the article “VA Bill Raising Bar For Biosimilars Substitution Falls In Line With BIO’s Principles.” The article said:

“The alliance principles call for physician authority to prevent the substitution, a requirement that physicians be notified of the product’s manufacturer and a notification process that doesn’t impose a burden on the pharmacist. The group also noted to Virginia lawmakers that ASBM and the Virginia Biotechnology Association hosted a September 2011 biosimilar education forum in Richmond that included local patient advocates and physicians.”

Read the article here.

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ASBM Hosts Biosimilars Forum at University of Rhode Island, College of Pharmacy

On December 13, ASBM hosted a Biosimilars Education Forum at the University of Rhode Island, College of Pharmacy in Kingston, RI, after ASBM members took a tour of a facility that manufactures biologic medicines. The forum brought together policymakers, patient advocates, physicians, pharmacists and other stakeholders who discussed the importance of patient safety as biosimilars are introduced in the United States.

Participants included:
Dr. Richard Dolinar, ASBM Chairman
Andrew Spiegel, CEO of the Colon Cancer Alliance
Ronald Jordan, Dean of the University of Rhode Island – College of Pharmacy
Bruce Babbitt, PAREXEL Consulting
Doug Kraus, patient advocate

Read more about the event here.

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Members Participate in CO BioScience Forum

A week before the RI event on December 6, several ASBM members took a tour of a biologic manufacturing facility in Longmont, CO and then attended a biosimilars forum hosted by Colorado BioScience, BIO and ASBM.

Dr. Dolinar participated in a panel discussion with Andrew Spiegel, CEO of the Colon Cancer Alliance, Philip Schneider, Associate Dean of the College of Pharmacy Administration at the University of Arizona and Fritz Bittenbender, Vice President of Alliance Development and State Government Affairs at BIO.

Read more here.

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Food and Drug Law Institute Publishes ASBM White Paper

The Food and Drug Law Institute (FDLI) Policy Forum published a white paper on biosimilar naming authored by ASBM.

In the paper, ASBM made four policy recommendations:

All biologics should receive distinct non-proprietary names.
United States Pharmacopeia (USP) should work with FDA to adapt the product monograph system to accommodate the unique attributes of structurally-related, but distinct, biologic medicines.
The non-proprietary name of a reference product and product/s biosimilar to it should have a common, shared root but have distinct and differentiating suffixes.
Products designated interchangeable should have a distinct name from the reference product for which they are considered interchangeable to facilitate accurate attribution of adverse events.

Read the paper here.

Biosimilar News featured an article on the paper, as did Generics and Biosimilars Initiative (GaBI).

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FDA Law Blog Post on White Paper

FDA Law discussed the ASBM white paper in the blog post “ASBM Says Distinct USAN Names for Biosimilars are Needed.” The blog points to ASBM’s call for:

“The need for clear, defined naming considerations and a system to implement an effective tracking and tracing of all biologics – not just biosimilars – stems from the potential of these products to be unexpectedly altered by the manufacturing process, handling, etc., in a manner that could cause unintended harm to patients. Whether the products that FDA approves will have the same name or a different name than the originator biologic will determine how well products can be traced back to a patient who has an adverse reaction.”

Read the blog here.

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Alliance for Patient Access Releases White Paper

AfPA National Physicians Biologics Working Group released a white paper entitled, “Biologics: Can Patients Get What the Doctor Orders?” that examines barriers to therapeutic access resulting from current healthcare benefits design. This is their second paper in a series designed as an educational resource to inform the public and policymakers about the benefits of biologics, what makes them unique and distinct from conventional pharmaceuticals, and why these distinctions matter.

Read the paper here.

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