February 23, 2012
Presented by Dr. Richard Dolinar, MD
February 22, 2012
Alliance to Host Capitol Hill Forum
The Alliance for Safe Biologic Medicines and Bloomberg Government will host a lunchtime Biosimilars Forum on Capitol Hill this coming Monday, February 27th, 2012 to discuss the FDA’s draft guidance documents on biosimilar product development.
Panelists include:
Brian Rye, Health-Care Financial Analyst with Bloomberg Government (moderator)
Dr. Richard Dolinar, Chairman of the Alliance for Safe Biologic Medicines
Dr. David Charles, Chief Medical Officer, Vanderbilt Neuroscience Institute, Chairman of the Alliance for Patient Access, and ASBM member partner
Seth Ginsberg, Co-Founder and President of the Global Health Living Foundation, and ASBM member partner
Andrew Spiegel, CEO and co-founder of the Colon Cancer Alliance, and ASBM member partner
Martha Raymond, Patient Advocate, Colon Cancer Alliance
Jeffrey P. Kushan, Partner, Sidley-Austin LLP
Location: Capitol Hill Visitors’ Center, Room 203-02
Date: February 27, 2012
Time: Noon
Please RSVP to rsvp@safebiologics.org by Friday, February 24 to attend.
February 15, 2012
The National Physicians Biologics Working Group today released an educational video featuring a discussion about the benefits of biologic therapies and how they differ from conventional pharmaceuticals. In the four minute video, David Charles, M.D., Chairman of the Alliance for Patient Access, discusses the importance of formulating public policies that ensure access to these biologic therapies while balancing issues relating to patient expense and safety. The video serves as an educational resource for policymakers, physicians and the public as they seek to gain a better understanding of the unique nature of biologic therapies. The video is available at AfPA’s YouTube channel.
Watch the video below:
February 14, 2012
The Alliance for Safe Biologic Medicines will host its third webinar on biologic and biosimilar medicines on Thursday, February 16, 2012. Click here to register!
The webinar will be hosted by Alliance Chairman Dr. Richard Dolinar. Registration is free!
Pharmacovigilance 101: What is it and why is it important?
Thursday, February 16, 3:00 PM ET
February 9, 2012
Urges FDA to put patient safety first as draft guidance finalized
WASHINGTON, Feb. 9, 2012 — In response to the release of the U.S. Food and Drug Administration’s long-awaited draft guidance on the approval of biosimilar medicines in the United States, Dr. Dolinar, Chairman of the Alliance for Safe Biologic Medicines (ASBM) issued the following statement:
“We welcome the FDA’s draft guidance on biosimilar product development and approval as an important step forward in expanding access to existing biological therapies.
“Biological medicines are more complex than chemical drugs and highly sensitive to the manufacturing process in ways that could have health consequences for patients. Therefore FDA’s regulation of biosimilars appropriately takes into account these special aspects of biologics and the need to ensure patient safety in light of them. In order to do this, FDA appropriately focuses on the need for clinical trials for biosimilar medicines, and labels that provide data doctors need to treat their patients. However, FDA should also require unique names to distinguish every biologic medicine and facilitate effective traceability of these products.
“We look forward to working with the FDA to ensure that biosimilars are as safe and effective as the biologics currently on the market. When it comes to patient safety there can be no shortcuts.”
Biologics are made from living organisms and treat serious conditions including cancer, multiple sclerosis and diabetes. In 2010, the U.S. Congress authorized the FDA to develop a pathway to approve biosimilars, which are the nonidentical copies of biologic medicines. For more information or to speak with Dr. Dolinar, please email media@safebiologics.org.
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. We serve as an authoritative resource center of information for the public, medical communities, the FDA and other state and federal policymakers during the implementation of the biosimilars pathway and beyond.
The Alliance for Safe Biologic Medicines provides factual information on biologic medications and advocates for policies that protect patient safety and ensure the accessibility of these products. More information available at www.safebiologics.org.
February 9, 2012
The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.
“When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers.”
The Patient Protection and Affordable Care Act, signed into law by President Obama on March 23, 2010, amended the Public Health Service Act to create an abbreviated approval pathway — under section 351(k) — for biological products that are demonstrated to be highly similar (biosimilar) to or interchangeable with an FDA-licensed biological product.
January 24, 2012
By Andrew Spiegel, Chief Executive Officer of the Colon Cancer Alliance (CCA)
MedCity News
The marathon battle against cancer continues but we are winning. New statistics from the American Cancer Society show the number of cancer-related deaths has decreased by about 23% in men and 15% in women since 1990. These promising reductions in the mortality rate are most apparent in lung, colon, breast, and prostate cancers, the most prevalent types, but there are also improvements for patients with rarer ones.
This is exciting news to the Colon Cancer Alliance, as we are committed to ending the pain and suffering caused by colorectal cancer.
Increased preventative measures and greater screenings explain in part the improvement in survivorship rates. Another reason is our better understanding of cancer. This has enabled the development of advanced biotech medicines, or biologics, which are now at the forefront of treatment.
January 4, 2012
By Helena R. Berger
Florida Sun Sentinel
January 4, 2012
A number of medical breakthroughs have helped individuals with severe and chronic disabilities. Many of these are biotech medicines, or biologics, which are advanced prescription drugs made from living organisms rather than chemicals. Biologics are used to treat serious disabilities like Multiple Sclerosis, Parkinson’s and Rheumatoid Arthritis.
Due to major complexities in the manufacturing process and patient safety concerns, biologics were never included in the 1984 legislation that regulates the production and marketing of generic drugs. In 2010, Congress instructed the U.S. Food and Drug Administration to create an approval pathway for attempted copies, known as biosimilars. The agency could release its guidance any day now, ushering in America’s first copycat biologic drugs.
January 4, 2012
By Helena R. Berger
Florida Sun Sentinel
January 4, 2012
A number of medical breakthroughs have helped individuals with severe and chronic disabilities. Many of these are biotech medicines, or biologics, which are advanced prescription drugs made from living organisms rather than chemicals. Biologics are used to treat serious disabilities like Multiple Sclerosis, Parkinson’s and Rheumatoid Arthritis.
Due to major complexities in the manufacturing process and patient safety concerns, biologics were never included in the 1984 legislation that regulates the production and marketing of generic drugs. In 2010, Congress instructed the U.S. Food and Drug Administration to create an approval pathway for attempted copies, known as biosimilars. The agency could release its guidance any day now, ushering in America’s first copycat biologic drugs.
December 21, 2011
By John Horton
Huffington Post
Seventeen years ago, Ronald Reagan penned what some have called his “Long Goodbye”: a letter to the American people announcing that he had been diagnosed with Alzheimer’s disease. He poignantly thanked readers for allowing him to serve as president. “I only wish there was some way I could spare Nancy from this painful experience,” he wrote.
Since then, Reagan’s public goodbye has been echoed in private by thousands upon thousands of parents and spouses: the painful recognition that Alzheimer’s currently has no cure, accompanied by a hope that someday, medicine will advance to the point where the disease can be prevented, managed or even cured.
Today, as we recognize Alzheimer’s prominence, what is the state of the medicine — are we any closer to fulfilling Reagan’s wish?
