Posts – Page 37 – Safe Biologics

FDA Launches Biosimilar Education Site for Prescribers

November 5, 2017

On October 23rd, the FDA launched a robust online resource center aimed at educating prescribers on biosimilars. The website includes fact sheets which explain regulatory terminology such as, “reference product” and “interchangeability”. The fact sheets also detail the biosimilar approval process as well as explain how these medicines are prescribed and substituted.

Sections include: Biosimilar and Interchangeable Products; Biosimilar Development, Review, and Approval; Prescribing Biosimilar and Interchangeable Products; Biosimilar Product Information; Industry Information and Guidance; Online Courses, Webinars, and Presentations; and Patient and Prescriber Outreach Materials. Drop in content, such as a newsletter article for prescribers, as well as social media posts are also made available by the FDA for circulation.

ASBM surveys of physicians worldwide have consistently shown the need for further education on biosimilars.

Visit the full FDA biosimilars site here.

FDA Launches Biosimilar Education Site for Prescribers

November 5, 2017

On October 23rd, the FDA launched a robust online resource center aimed at educating prescribers on biosimilars. The website includes fact sheets which explain regulatory terminology such as, “reference product” and “interchangeability”. The fact sheets also detail the biosimilar approval process as well as explain how these medicines are prescribed and substituted.

Sections include: Biosimilar and Interchangeable Products; Biosimilar Development, Review, and Approval; Prescribing Biosimilar and Interchangeable Products; Biosimilar Product Information; Industry Information and Guidance; Online Courses, Webinars, and Presentations; and Patient and Prescriber Outreach Materials. Drop in content, such as a newsletter article for prescribers, as well as social media posts are also made available by the FDA for circulation.

ASBM surveys of physicians worldwide have consistently shown the need for further education on biosimilars.

Visit the full FDA biosimilars site here.

New York Becomes 36th State to Pass Biosimilar Substitution Law

November 5, 2017

On Monday, October 23rd, Governor Andrew Cuomo signed biosimilars legislation (S.4788A/A.7509A) regarding the pharmacy substitution of interchangeable biosimilar medical products—a measure ASBM and others have pursued in New York over the past two years.

New York is now the 36th state to pass biosimilars substitution legislation. This law (Chapter 357 of the Laws of 2017) will pave the way for interchangeable biologic substitution in the State of New York while enhancing patient access to biosimilars. It ensures pharmacy-physician communication by requiring that the pharmacist notify the physician which biologic the patient received without posing undue or onerous burdens on pharmacists. It also requires a pharmacist to inform the patient which product, innovator or biosimilar, he or she has been prescribed. Lastly, it allows for physicians to prohibit substitution should they deem it necessary. This legislation keeps treatment decisions within the purview of the physician and the patient.

This legislation would not have passed without the overwhelming support of the physician and patient communities in the state.

See ASBM’s recent letter to the NY Governor here.

New York Becomes 36th State to Pass Biosimilar Substitution Law

November 5, 2017

On Monday, October 23rd, Governor Andrew Cuomo signed biosimilars legislation (S.4788A/A.7509A) regarding the pharmacy substitution of interchangeable biosimilar medical products—a measure ASBM and others have pursued in New York over the past two years.

New York is now the 36th state to pass biosimilars substitution legislation. This law (Chapter 357 of the Laws of 2017) will pave the way for interchangeable biologic substitution in the State of New York while enhancing patient access to biosimilars. It ensures pharmacy-physician communication by requiring that the pharmacist notify the physician which biologic the patient received without posing undue or onerous burdens on pharmacists. It also requires a pharmacist to inform the patient which product, innovator or biosimilar, he or she has been prescribed. Lastly, it allows for physicians to prohibit substitution should they deem it necessary. This legislation keeps treatment decisions within the purview of the physician and the patient.

This legislation would not have passed without the overwhelming support of the physician and patient communities in the state.

See ASBM’s recent letter to the NY Governor here.

CMS Reverses Course on Shared Billing Codes for Biosimilars

November 5, 2017

On November 2nd, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a final rule for the 2018 Physician Fee Schedule, which governs reimbursement rates for physicians.

In a significant development, beginning in 2018 CMS will update payment for biosimilars. Under the previous rule finalized in 2015 under the Obama Administration, all of the biosimilars sharing one reference product shared a single billing code. The initial policy had faced broad opposition from manufacturers of biologics and biosimilars, as well as representatives of the physician, pharmacist, and patient communities. ASBM was among these opponents.

On September 11, 2017, ASBM submitted comments to CMS which reiterated our concerns in detail and urged CMS to reconsider the policy. From the comments:

[The use of shared billing codes] disproportionately prioritizes cost among the many factors that go into making a treatment decision. These include whether or not a biosimilar was approved for a particular indication; whether its comparability to the reference product was ever demonstrated by studies in that indication or whether its effects were merely extrapolated from studies in different indications; whether the FDA determined the biosimilar is “interchangeable” with its reference product (producing the same effects without additional risks); product features such as ease and frequency of administration; the quality of patient support programs; the degree of discomfort associated with injections; whether it can it be administered at home; and whether it will be consistently available (not subject to shortages).

Second, the use of a shared identifier for multiple different biologic products implies an identicality between them which does not exist and an interchangeability between them that may or may not have been demonstrated…

Finally, shared codes may also have the unintended consequence of disincentivizing biosimilar development itself. Regardless of whether a manufacturer develops a less expensive manufacturing process or a delivery system that makes compliance more likely or reduces waste but costs more, they will be paid at the same rate. Reduced biosimilar development means reduced price competition, which could jeopardize any potential cost savings to patients and payers.

This shift in policy promotes competition to ensure millions of patients will have access to new lower cost therapies. Michael Reilly, Executive Director of ASBM praised the move: “Under the leadership of Administrator Verma, CMS has adopted a policy that makes sense for patients. It promotes the development of new therapeutic options, brings down costs, and improves pharmacovigilance. It’s a major victory for patients.”

Read more about the CMS decision here.

ASBM Presents at 65th WHO Naming Meeting

October 20, 2017

On October 17th, ASBM Chair, Madeline Feldman, M.D., FACR; Advisory Board Chair, Philip Schneider, MS, FASHP; and Executive Director, Michael Reilly, Esq. appeared before the 65th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland.

ASBM has regularly appeared before the INN Consultation since 2013 and continues to advocate for distinguishable naming of biologics — more recently in support of the adoption of a Biological Qualifier (BQ) proposal as a solution on naming. The BQ proposal is a random, non-memorable 4-letter consonant only suffix that would be assigned to all biological active substances.

Should the WHO advance the BQ proposal, it would give other nations around the world a model that they may choose to adopt, thereby creating a world standard. ASBM surveys have shown strong support for distinct naming among physicians worldwide. Sixty-six percent of U.S. physicians surveyed support distinct naming for all biologics including biosimilars, as do 68% of Canadian and 79% of Australian physicians. Among physicians in Latin America, 94% believe the WHO’s BQ proposal would be helpful in ensuring their patients receive the correct medicine.

In advance of the trip to Geneva, ASBM submitted a letter to the Director General
of the WHO, Dr. Tedros Adhanom Ghebreyesus, advocating for the swift implementation of the BQ proposal. In July 2014, the INN Expert Group put forward the BQ recommendation for a distinguishable naming approach, however to date, this policy has yet to be implemented.

ASBM’s letter stated:

“The BQ has the potential to become at an important adjunct to global pharmacovigilance systems for all biologic medicines and it should be implemented before further proliferation of national naming schemes occurs. This is especially important for those countries who have less developed pharmacovigilance systems, and who may not have appropriate naming policies in place for biologics and biosimilars.”

Read full letter here.

Alliance for Safe Biologic Medicines Releases 2017 Canadian Prescriber Survey

October 17, 2017

For Immediate Release

~National survey reveals physician attitudes on key policy issues related to
originator biologics and biosimilars ~

Ottawa, Ontario (November 22, 2017)  A new national survey conducted by the Alliance for Safe Biologic Medicines (ASBM) found that Canadian physicians overwhelmingly support distinguishable names for all biologics, including biosimilars. Survey results also found that Canadian physicians are open to substituting biosimilars for non-medical reasons, only when they are the ultimate decision maker for their patient, not a third-party.

The results of the survey were recently presented at the Drug Information Association (DIA) Annual Canadian meeting in Ottawa by ASBMs immediate past chairman, Harry Gewanter, M.D.

Distinguishable non-proprietary naming for all biologic medicines is important for the appropriate use of originator biologics and biosimilars, as well as pharmacovigilance, said Gewanter. Further, Canadian physicians believe it is critical that the physician-patient relationship remains central when deciding which treatments their patients will utilize.”

The 2017 ASBM Canadian physician survey is a follow-up to a previous survey conducted in 2014 and includes 403 physicians across 13 major therapeutic specialties all of whom prescribe biologics. ASBMs first Canadian survey was commissioned by ASBM in 2014 to provide empirical data to Health Canada, provincial policymakers, and other health regulators.

Survey results show that Canadian physicians knowledge of biosimilars has improved significantly over the last three years, with a nearly-threefold increase in respondents stating they were very familiar with biosimilars (10 per cent in 2014 increasing to 28 per cent in 2017).

On the clinical implications of public policy issues concerning originator biologics and biosimilars, survey results showed:

On the naming of originator biologics and biosimilars:[1]

68 per cent of physicians support Health Canada implementing distinguishable names, yet there was no consensus as to best method.
54 per cent believe a biosimilar which shares an INN with its reference product implies the two are structurally identical, which is not the case; and
63 per cent believe a biosimilar which shares an INN with its reference product implies the two were approved for the same indications, which may or may not be the case.

On pharmacy substitution of a biosimilar in place of a prescribed originator biologic:[2]

83 per cent considered it very important or critical that the prescribing physician decide the most suitable biologic for their patients;
79 per cent considered it very important or critical to have the authority to designate on a prescription for a biologic medicine Dispense as Written or Do Not Substitute;
78 per cent considered it very important or critical to be notified in the event a biosimilar is substituted at the pharmacy; and
82 per cent of physicians support switching studies before a third party may automatically substitute biosimilars.

The results of our survey provide important insight and evidence to regulators and policymakers on the perspectives of Canadian prescribers of biologic medicines,” said Michael Reilly, Executive Director of ASBM. For originator biologics and biosimilars to be used successfully, decision makers should rely on the input and opinions of those who prescribe them, working collaboratively to develop policies that minimize potential safety or efficacy issues.

For nearly seven years, ASBM has commissioned physician surveys to gather the perspectives of biologic prescribers worldwide. The full results of the 2017 Canadian survey, as well as ASBM’s other surveys, may be viewed at www.SafeBiologics.org/surveys.

About the Survey

The Alliance for Safe Biologic Medicines (ASBM) surveyed 403 Canadian prescribers of biologics with a 15-minute web survey. Respondents were selected from selected from 13 therapeutic specialties, including: Allergy/Immunology (3 per cent), Dermatology (21 per cent), Endocrinology (9 per cent), Gastroenterology (9 per cent) Hematology/Oncology (5 per cent), Infectious Diseases (1 per cent), Internal Medicine (19 per cent), Nephrology (3 per cent), Neurology (5 per cent), Oncology (9 per cent), Respiratory/Pulmonology (6 per cent), Rheumatology (10 per cent), and Urology (2 per cent). All prescribe biologic medicines in their practice.

About the Alliance for Safe Biologic Medicines

The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.

For more information, please contact:

Sunil Suvarna

Hill+Knowlton Strategies

1-778-772-5133

Sunil.Suvarna@hkstrategies.ca

[1] Alliance for Safe Biologic Medicines (ASBM). 2017 Canadian Prescriber Survey.

[2] Alliance for Safe Biologic Medicines (ASBM). 2017 Canadian Prescriber Survey.