Comment

PBSA’s Statement on January 17th’s Draft Interchangeability Guidance

PBSA’s Statement on Today’s Draft Interchangeability Guidance

 

January 17, 2016

Patients for Biologics Safety and Access (PBSA) commends the FDA on today’s release of the draft interchangeability guidance, and looks forward to working with the agency to address a significant number of questions held by patients. PBSA has long believed that guidance on the interchangeability of biologic products is a necessity to ensure patient safety and to build patient confidence in the new category of therapies known as biosimilars. Today’s guidance document is a critical step on the path to providing that safety and confidence.

Comment

Comment

PATIENT ADVOCACY GROUPS URGE FOR GREATER VOICE AS HOUSE ENERGY AND COMMERCE COMMITTEE REVIEWS FDA BIOSIMILAR APPROVAL PROCESS

FOR IMMEDIATE RELEASE

PATIENT ADVOCACY GROUPS URGE FOR GREATER VOICE AS HOUSE ENERGY AND COMMERCE COMMITTEE REVIEWS FDA BIOSIMILAR APPROVAL PROCESS

Patient Groups Call for Patient Safety to be Top Priority for FDA Consideration of Biosimilars

WASHINGTON – February 4, 2016- The House Committee on Energy and Commerce’s Subcommittee on Health today held a hearing to examine U.S. Food and Drug Administration (FDA) implementation of the Biologics Price and Competition and Innovation Act (BPCIA). Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at the FDA and Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare at the Centers for Medicare and Medicaid Services (CMS) provided testimony. However, no patient groups were asked to provide testimony during the hearing.

Comment

Comment

OPED BY LARRY LAMOTTE: THE HILL: FDA MUST PUT PATIENTS FIRST IN BIOSIMILAR APPROVAL PROCESS

The House Committee on Energy and Commerce will hold an oversight hearing today, Feb. 4, on a new class of drugs, biosimilars, and the Food and Drug Administration’s (FDA) system for approving and monitoring them.

A biosimilar is highly similar to, but not an exact copy of, a biologic. Biologic drugs are complex therapies made from living organisms that are far more complicated and more difficult to develop and manufacture than traditional chemical drugs. Many are produced using a technology that extracts and combines DNA from plant or animal cells. Due to the uniqueness and complexity of biologics, they are impossible to copy in a generic form.

The introduction of biologic products to treat chronic and rare diseases has been the most significant advancement in patient care in recent decades. These drugs have provided many patients an effective therapy, some for the first time in their lives.

Comment

Comment

Oped by Larry LaMotte: Morning Consult: Patient Voice is Paramount to New FDA Approval of Biosimilars

The Senate Committee on Health, Education, Labor and Pensions (HELP) held an oversight hearing yesterday on the Food and Drug Administration’s (FDA) system for approving a new class of drugs – biosimilars. The hearing was a significant step in making sure that the focus of the biosimilar approval process is on what is best for patient health.

Biologic drugs are a relatively new and unique category of pharmaceuticals – they are derived from living organisms and are far more complex and difficult to produce than traditional chemical drugs. For patients diagnosed with everything from immunodeficiency diseases to rheumatoid arthritis and psoriasis, biologic drugs are life-changing and are expanding treatment opportunities previously thought impossible.

As part of the Affordable Care Act, Congress created an abbreviated pathway to market for so-called “biosimilar” drugs.

Comment

Comment

PBSA Statement On FDA Draft Guidance on Naming of Biologics

(August 27, 2015) Patients for Biologics Safety & Access (PBSA), a coalition of over 20 patient advocacy organizations dedicated to protecting patient access to safe and effective biologics, today released the following statement regarding the draft guidance on the naming of biosimilars and biologics put forward today by the Food and Drug Administration (FDA):

“Patients for Biologics Safety and Access (PBSA) are pleased with the FDA’s commitment to unique non-proprietary names of biosimilars.  Unique distinguishable names for all biological medications are needed to ensure accurate tracking of medication utilization and adverse events, reduce patient and physician confusion and to enable a transparent system.   PBSA will provide further suggestions to the FDA on issues on which they have requested more public input.   One area we are particularly interested in is the development of and adverse event reporting system that is functional and universal.” 

About Patients for Biologics Safety & Access

Patients for Biologics Safety & Access is a national coalition representing more than 20 patient advocacy organizations. The goal of the organization is to make sure the voices and interests of patients are heard as the FDA seeks to approve a new category of drugs known as biosimilars. For more information, visit www.BiosimSafety.org or @BiosimSafety

American Autoimmune Related Diseases Association

Arthritis Foundation

Committee of Ten Thousand

Crohn’s & Colitis Foundation of America

Dystonia Medical Research Foundation

GBS/CIDP Foundation International

Hemophilia Federation of America

Hepatitis Foundation International

Immune Deficiency Foundation

International Foundation for Autoimmune Arthritis

Jeffrey Modell Foundation

Lupus and Allied Diseases Association

Lupus Foundation of America

National Alliance on Mental Illness

National Organization for Rare Disorders

National Psoriasis Foundation

Platelet Disorder Support Association

Pulmonary Hypertension Association

Scleroderma Foundation

Spondylitis Association of America

United Spinal Association

US Hereditary Angioedema Association

###

 

Comment

Comment

Patient Groups Send Letter to FDA Expressing Concern over Diminished Safety Standards for Biosimilars

PBSA calls for strong and clear review standards to protect patient safety

(June 09, 2015) Patients for Biologics Safety & Access (PBSA), a coalition of over 20 patient advocacy organizations dedicated to protecting patient access to safe and effective biologics, today sent a letter to the United States Food and Drug Administration (FDA) questioning the final guidance documents issued for biosimilars and concerns that the final guidances diminish patient safety protections. 

“As representatives of millions of American patients and their families, we applaud the FDA for issuing final guidances on important aspects of the Biologics Pricing Competition and Innovation Act (BPCIA). We remain concerned that instead of strengthening patient safeguards the final guidance documents diminish transparency and patient safety protections from the original draft guidances. The final guidances removed language that called for a biosimilar to be labeled as a biosimilar and to indicate whether or not the biosimilar is interchangeable with the reference product. In addition, the final guidance provides greater opportunity for the use of indication extrapolation for biosimilars,” said Larry LaMotte, Vice President of the Immune Deficiency Foundation, a member of PBSA.

Comment

Comment

PBSA Sends Letter to FDA Expressing Concerns About the FDA Advisory Committee Process for Biosimilars.

Patients for Biologics Safety & Access Sends letter to FDA expressing concerns About the FDA Advisory Committee Process for Biosimilars

 

In Letter to the FDA, Patient Advocates Cite Concerns About Lack of Experts on Advisory Committee Panels and Final Approval Standards for Biosimilars

 

May 06, 2015 – Patients for Biologics Safety & Access, a coalition of over 20 patient advocacy organizations dedicated to protecting patient access to safe and effective biologics, today announced that they have sent a letter to the U.S. Food and Drug Administration (FDA) urging the Agency to include experts with institutional knowledge of the review criteria and process for biosimilars on forthcoming Advisory Committees and ensuring the Agency initiates notice-and-comment rulemaking on critical patient safety issues before approving any additional biosimilars.

 

“Currently, the FDA is structuring the Advisory Committees by therapeutic areas. The Oncologic Drugs Advisory Committee reviewed the first biosimilar application for filgrastim and the Arthritis Advisory Committee is scheduled to review the second biosimilar application for infliximab. This structure allows for no provision of adequate expertise in the biosimilar review standards and process. Each committee will be new to the review criteria and process for biosimilars. This leaves the Committees overly reliant on FDA for guidance on making its recommendations on the approval of biosimilars,” said Patients for Biologics Safety & Access in the letter.

 

Biologics are complex medicines that are made from living cells. “Biosimilars” are biologics that are similar, but not identical to, a previously approved biologic. Unlike generic versions of small-molecule drugs, there can never be identical versions of biologic drugs.

 

“Patient safety needs to be at the forefront as the FDA approves biosimilars. The FDA has finalized several guidance documents regarding biosimilars, but the Agency has yet to issue final guidance on crucial patient safety issues such as interchangeability standards, pharmacovigilance monitoring system and naming. Given the importance of this issue to patient safety, we are asking that you take the necessary steps to issue final approval standards and processes and ensure the Advisory Committee members have expertise with biologics,” the patient groups added in the letter. 

The full letter can be found here.

 

Comment

Comment

PBSA Statement on HELP Committee Letter to FDA

Patient Groups Applaud Senators for Raising Critical Patient Safety Questions about Biosimilars

PBSA calls for additional oversight and committee hearing to address patient safety concerns

(May 01, 2015) Patients for Biologics Safety & Access (PBSA), a coalition of over 20 patient advocacy organizations dedicated to protecting patient access to safe and effective biologics, today released the following statement regarding the letter from nine members of the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) sent to the Food and Drug Administration (FDA) urging the agency to provide clarity and certainty on the biosimilar drug approval process: 

“As representatives of millions of American patients and their families, we applaud Chairman Alexander and the members of the Senate HELP Committee for calling attention to critical issues facing the FDA’s approval of biosimilars. Clear guidance on the processes and standards from FDA is needed before additional biosimilars are approved. We remain concerned the FDA has yet to issue final guidance on a range of issues that will impact patient safety, including interchangeability, naming, and indication extrapolation.

“Our communities are eager for new and affordable treatments, but patients with rare and chronic diseases are keenly aware of the possible risks associated with biosimilars. Chairman Alexander and the members of the Senate HELP Committee have raised important questions with the FDA, and a full committee hearing should be held on biosimilars to ensure patient concerns are addressed.”

Chairman Lamar Alexander (R-TN) was joined by Sens. Michael Enzi (R-WY), Richard Burr (R-NC), Johnny Isakson (R-GA), Mark Kirk (R-IL), Orrin Hatch (R-UT), Pat Roberts (R-KS), Sen. Susan Collins (R-ME), and Bill Cassidy, M.D. (R-LA) in calling for final guidance from the FDA. The press release and ful letter can be viewed HERE.  

About Patients for Biologics Safety & Access

Patients for Biologics Safety & Access is a national coalition representing more than 20 patient advocacy organizations. The goal of the organization is to make sure the voices and interests of patients are heard as the FDA seeks to approve a new category of drugs known as biosimilars. For more information, visit www.BiosimSafety.org or @BiosimSafety

American Autoimmune Related Diseases Association

Arthritis Foundation

Committee of Ten Thousand

Crohn’s & Colitis Foundation of America

Dystonia Medical Research Foundation

GBS/CIDP Foundation International

Hemophilia Federation of America

Hepatitis Foundation International

Immune Deficiency Foundation

Jeffrey Modell Foundation

Lupus and Allied Diseases Association

Lupus Foundation of America

National Alliance on Mental Illness

National Organization for Rare Disorders

National Psoriasis Foundation

Platelet Disorder Support Association

Pulmonary Hypertension Association

Scleroderma Foundation

Spondylitis Association of America

United Spinal Association

US Hereditary Angioedema Association

 

###

 

Comment

Comment

Inside Health Policy: Senators Question FDA’s Authority to Use ‘Placeholder’ Biosimilar Name

Senate health committee chair Lamar Alexander (R-TN) led a group of Republican senators in expressing anxiety about unresolved questions concerning FDA's implementation of the biosimilar pathway, saying the agency's “failure” to resolve fundamental questions -- such as naming -- before approving the first biosimilar last month “raises a number of serious concerns.” The senators especially take aim at FDA's authority around using a “placeholder” name for the first biosimilar approved in March.

The lawmakers say: “FDA has not provided sufficient guidance on important issues relating to the review and approval of license applications for biosimilar products, such as naming, interchangeability, and production of patent information.”

Alexander was joined by Republican Sens. Michael Enzi (WY), Richard Burr (NC), Johnny Isakson (GA), Mark Kirk (IL), Orrin Hatch (UT), Pat Roberts (KS) and Bill Cassidy (LA).

The lawmakers especially question FDA's use of a “placeholder” name for the first approved biosimilar -- Sandoz's filgrastim drug product, which carries the placeholder name filgrastim-sndz.

“It is unclear to us what it means for a nonproprietary name to be a 'placeholder,' what authority FDA has to make such a designation, or what treatment a 'placeholder' name will receive once FDA formalizes a naming policy,” they say. “In addition, we are concerned that hospitals, consumers, patients, doctors, and others may be confused by a name that appears temporary or not fully approved.”

Read the full article at Inside Health Policy.

Comment

Comment

Roll Call: Congress Should Hold Oversight Hearings to Ensure FDA Prioritizes Safety for Biosimilars

The Food and Drug Administration recently approved the first in a new category of biologic drugs known as “biosimilars,” and soon will consider approval of others. Although biosimilars have great potential for improving patient access to life-saving biologic medicines, congressional oversight is needed to ensure patient safety guides the biosimilar approval process at the FDA.

Biologic medicines are made from living organisms and are far more complex and difficult to develop than traditional chemical drugs. The advent of biologic medicines has saved and transformed the lives of Americans who have been diagnosed with many serious and life-threatening conditions.

For individuals living with spinal cord injury and/or disease, access to biologic treatments is necessary to control symptoms and relieve pain. The potential arrival of biosimilars to the market brings promise of new therapies to our community but also carries potential risk.

The Biologics Price Competition and Innovation Act, signed into law in 2010, established new regulatory authority for the FDA to review and approve biosimilars. Biosimilars are medicines that are highly similar, but not identical, to innovative biologic medicines. Under this new law, the agency recently approved the first biosimilar in the United States.

Comment