January 2015 Newsletter

February 11, 2015

State Update

 

As states are beginning their legislative sessions for the year, there are many biosimilar bills that have been introduced. ASBM supports legislation that encourages open communication between physicians and pharmacists where physicians know exactly which product is dispensed to patients.  We applaud the many states that are including this important provision and will work together with those states that have not, to help ensure positive patient outcomes.

A few states where legislation is pending, include:

Colorado

On February 5, the Senate passed SB 71, a bill ASBM supports that includes a prescriber communication provision. 

Georgia
SB 51 and HB 195 have been introduced in Georgia with communication language and hearings are expected to be held soon. The Medical Association of Georgia testified in support of SB 51 during a subcommittee meeting on February 4 and letters supporting both bills are encouraged.

Idaho

On January 26, the Idaho Senate Health Committee held a hearing on the proposed Board of Pharmacy rule on biosimilars that does not include prescriber communication. We are encouraging legislators to reject the rule and work towards a better solution that prioritizes patient safety.

New Jersey

Legislation in New Jersey is being considered and letters supporting bill A2477, S1705 are needed. Read ASBM’s letter here.

We are monitoring legislation in many other states and will provide updates as we have them.

Hamburg Steps Down

Dr. Margaret Hamburg, U.S. Food and Drug Administration (FDA) commissioner over the past six years, announced on February 5 that she was stepping down. 

Read more here.

ASBM Quoted in Inside Health Policy 

On January 6, the FDA released the 2015 Guidance Agenda that will be issued by the Center for Drug Evaluation and Research (CDER) as they prepare for the first biosimilar approval that could be as early as March. The guidance agenda slates four biosimilar documents the agency plans to put out this year including one on labeling, but there is no mention of a guidance specifically on the naming issue.

Inside Health Policy interviewed ASBM Executive Director Michael Reilly for the article “FDA Guidance Agenda Doesn’t List Biosimilar Naming, But Includes Labeling.” In the article, Mr. Reilly points out that labeling is a separate issue and will likely not resolve the naming debate and that FDA’s stance on naming will have a global implication, whereas the biosimilar naming approach will have a smaller impact.

Read the full article here.

New Videos Explain Differences Between Biologics and Biosimilars 

Amgen Canada has created two new videos explaining what biologics and biosimilars are and how these highly complex medicines differ from each other. The videos show why manufacturing really matters and the importance of patient safety as biosimilars are approved.

Read more here.

ASBM Advisory Board Chair Quoted in Pharmacy Today 

The American Pharmacists Association publication, Pharmacy Today, featured an article on biosimilars and quoted Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and ASBM International Advisory Board Chair. 

In “Pharmacy Today: Pharmacists and health systems prepare to add biosimilars to formularies“ he said:

“Even if a drug is considered similar, it should be easily identified. There’s been a longstanding principle in health care that pharmacists have used to avoid look-alike, sound-alike drug names, so the industry’s been asked to change drug names so there aren’t those kinds of mix-ups,” said Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and a member of the international advisory board to the Alliance for Safe Biologic Medicines. “Once a decision is made, it should be very clear what drug the patient’s receiving.”

Read the full article here.

CE Class on Biosimilars for Pharmacists

ASBM’s CE class for pharmacists on the fundamentals of biologics that is being offered through the Long Island School of Pharmacy will be on March 15. The five-hour class “The Fundamentals of Biosimilars: What Every Pharmacist Will Need to Know” will explain what biologics and biosimilars are, how they are manufactured and regulatory challenges associated with them. 

Read more here.

Upcoming Conferences:

  • February 23-25: Biosimilars and Follow-on Biologics 2015 Americas in Washington, DC
  • March 4-5: Biosimilar Drug Development World in Madrid, Spain
  • April 13-15: WHO 60th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland
  • April 20-21: 2015 FDLI Annual Conference in Washington, DC 

 

February 2015 Newsletter

February 10, 2015

State Update

 

As states are beginning their legislative sessions for the year, there are many biosimilar bills that have been introduced. ASBM supports legislation that encourages open communication between physicians and pharmacists where physicians know exactly which product is dispensed to patients.  We applaud the many states that are including this important provision and will work together with those states that have not, to help ensure positive patient outcomes.

 

A few states where legislation is pending, include:

 

Colorado
On February 5, the Senate passed SB 71, a bill ASBM supports that includes a prescriber communication provision. 

 

Georgia
SB 51 and HB 195 have been introduced in Georgia with communication language and hearings are expected to be held soon. The Medical Association of Georgia testified in support of SB 51 during a subcommittee meeting on February 4 and letters supporting both bills are encouraged.

 

Idaho

On January 26, the Idaho Senate Health Committee held a hearing on the proposed Board of Pharmacy rule on biosimilars that does not include prescriber communication. We are encouraging legislators to reject the rule and work towards a better solution that prioritizes patient safety.

 

New Jersey

Legislation in New Jersey is being considered and letters supporting bill A2477, S1705 are needed. Read ASBM’s letter here.

 

We are monitoring legislation in many other states and will provide updates as we have them.

 

 


ASBM Quoted in Inside Health Policy 

 

On January 6, the FDA released the 2015 Guidance Agenda that will be issued by the Center for Drug Evaluation and Research (CDER) as they prepare for the first biosimilar approval that could be as early as March. The guidance agenda slates four biosimilar documents the agency plans to put out this year including one on labeling, but there is no mention of a guidance specifically on the naming issue.

 

Inside Health Policy interviewed ASBM Executive Director Michael Reilly for the article “FDA Guidance Agenda Doesn’t List Biosimilar Naming, But Includes Labeling.” In the article, Mr. Reilly points out that labeling is a separate issue and will likely not resolve the naming debate and that FDA’s stance on naming will have a global implication, whereas the biosimilar naming approach will have a smaller impact.

 

Read the full article here.

 

Hamburg Steps Down


Dr. Margaret Hamburg, U.S. Food and Drug Administration (FDA) commissioner over the past six years, announced on February 5 that she was stepping down. 

Read more here.

 


New Videos Explain Differences Between Biologics and Biosimilars 

Amgen Canada has created two new videos explaining what biologics and biosimilars are and how these highly complex medicines differ from each other. The videos show why manufacturing really matters and the importance of patient safety as biosimilars are approved.

Read more here.


ASBM Advisory Board Chair Quoted in Pharmacy Today 

The American Pharmacists Association publication, Pharmacy Today, featured an article on biosimilars and quoted Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and ASBM International Advisory Board Chair.

In “Pharmacy Today: Pharmacists and health systems prepare to add biosimilars to formularies” he said:

“Even if a drug is considered similar, it should be easily identified. There’s been a longstanding principle in health care that pharmacists have used to avoid look-alike, sound-alike drug names, so the industry’s been asked to change drug names so there aren’t those kinds of mix-ups,” said Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and a member of the international advisory board to the Alliance for Safe Biologic Medicines. “Once a decision is made, it should be very clear what drug the patient’s receiving.”

Read the full article here.

 

CE Class on Biosimilars for Pharmacists

ASBM’s CE class for pharmacists on the fundamentals of biologics that is being offered through the Long Island School of Pharmacy will be on March 15. The five-hour class “The Fundamentals of Biosimilars: What Every Pharmacist Will Need to Know” will explain what biologics and biosimilars are, how they are manufactured and regulatory challenges associated with them. 


Read more here.

 

 


Upcoming Conferences:

  • February 23-25: Biosimilars and Follow-on Biologics 2015 Americas in Washington, DC
  • March 4-5: Biosimilar Drug Development World in Madrid, Spain
  • April 13-15: WHO 60th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland
  • April 20-21: 2015 FDLI Annual Conference in Washington, DC 

February 2015 Newsletter

February 10, 2015

State Update

 

As states are beginning their legislative sessions for the year, there are many biosimilar bills that have been introduced. ASBM supports legislation that encourages open communication between physicians and pharmacists where physicians know exactly which product is dispensed to patients.  We applaud the many states that are including this important provision and will work together with those states that have not, to help ensure positive patient outcomes.

 

A few states where legislation is pending, include:

 

Colorado
On February 5, the Senate passed SB 71, a bill ASBM supports that includes a prescriber communication provision. 

 

Georgia
SB 51 and HB 195 have been introduced in Georgia with communication language and hearings are expected to be held soon. The Medical Association of Georgia testified in support of SB 51 during a subcommittee meeting on February 4 and letters supporting both bills are encouraged.

 

Idaho

On January 26, the Idaho Senate Health Committee held a hearing on the proposed Board of Pharmacy rule on biosimilars that does not include prescriber communication. We are encouraging legislators to reject the rule and work towards a better solution that prioritizes patient safety.

 

New Jersey

Legislation in New Jersey is being considered and letters supporting bill A2477, S1705 are needed. Read ASBM’s letter here.

 

We are monitoring legislation in many other states and will provide updates as we have them.

 

 


ASBM Quoted in Inside Health Policy 

 

On January 6, the FDA released the 2015 Guidance Agenda that will be issued by the Center for Drug Evaluation and Research (CDER) as they prepare for the first biosimilar approval that could be as early as March. The guidance agenda slates four biosimilar documents the agency plans to put out this year including one on labeling, but there is no mention of a guidance specifically on the naming issue.

 

Inside Health Policy interviewed ASBM Executive Director Michael Reilly for the article “FDA Guidance Agenda Doesn’t List Biosimilar Naming, But Includes Labeling.” In the article, Mr. Reilly points out that labeling is a separate issue and will likely not resolve the naming debate and that FDA’s stance on naming will have a global implication, whereas the biosimilar naming approach will have a smaller impact.

 

Read the full article here.

 

Hamburg Steps Down


Dr. Margaret Hamburg, U.S. Food and Drug Administration (FDA) commissioner over the past six years, announced on February 5 that she was stepping down. 

Read more here.

 


New Videos Explain Differences Between Biologics and Biosimilars 

Amgen Canada has created two new videos explaining what biologics and biosimilars are and how these highly complex medicines differ from each other. The videos show why manufacturing really matters and the importance of patient safety as biosimilars are approved.

Read more here.


ASBM Advisory Board Chair Quoted in Pharmacy Today 

The American Pharmacists Association publication, Pharmacy Today, featured an article on biosimilars and quoted Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and ASBM International Advisory Board Chair.

In “Pharmacy Today: Pharmacists and health systems prepare to add biosimilars to formularies” he said:

“Even if a drug is considered similar, it should be easily identified. There’s been a longstanding principle in health care that pharmacists have used to avoid look-alike, sound-alike drug names, so the industry’s been asked to change drug names so there aren’t those kinds of mix-ups,” said Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and a member of the international advisory board to the Alliance for Safe Biologic Medicines. “Once a decision is made, it should be very clear what drug the patient’s receiving.”

Read the full article here.

 

CE Class on Biosimilars for Pharmacists

ASBM’s CE class for pharmacists on the fundamentals of biologics that is being offered through the Long Island School of Pharmacy will be on March 15. The five-hour class “The Fundamentals of Biosimilars: What Every Pharmacist Will Need to Know” will explain what biologics and biosimilars are, how they are manufactured and regulatory challenges associated with them. 


Read more here.

 

 


Upcoming Conferences:

  • February 23-25: Biosimilars and Follow-on Biologics 2015 Americas in Washington, DC
  • March 4-5: Biosimilar Drug Development World in Madrid, Spain
  • April 13-15: WHO 60th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland
  • April 20-21: 2015 FDLI Annual Conference in Washington, DC 

Support for A2477 in NJ

February 4, 2015

On February 2, ASBM sent a letter to New Jersey Assemblywoman Pamela Lampitt supporting A2477, the bill she sponsored.

Read the letter here.

Support for A2477 in NJ

February 4, 2015

On February 2, ASBM sent a letter to New Jersey Assemblywoman Pamela Lampitt supporting A2477, the bill she sponsored.

Read the letter here.

Washington Post: The coming revolution in much cheaper life-saving drugs

January 17, 2015

Randy Hillard was supposed to be dead by now. In 2010, the Michigan State University psychiatry professor was diagnosed with stage four stomach cancer and given less than a year to live. He started wondering how he could die in the most comfortable way possible given the circumstances, even briefly researching an assisted suicide organization in Switzerland.

But Hillard, now 63 years old, lucked out. Around the same time he received his diagnosis, a breast cancer drug called Herceptin was approved to treat some forms of stomach cancer. For more than four years, a Herceptin infusion taken once every three weeks has kept Hillard alive – at a cost of $1 million, he estimates, with about $100,000 coming from his own pocket.

“I can barely afford that, and I’m a doctor,” he said.

So the vote that Hillard cast on a Food and Drug Administration panel earlier this month had some extra significance. Meeting at the FDA’s Silver Spring campus, the panel recommended the approval of the first in a new class of drugs called “biosimilars” – a type of generic drug that’s never before been available in the United States and would potentially save him and patients like him thousands of dollars.

Read full article here.

Pharmacy Today: Pharmacists and health systems prepare to add biosimilars to formularies

January 14, 2015

The American Pharmacists Association publication, Pharmacy Today, featured an article on biosimilars and quoted Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and ASBM  international advisory board member. In the article he said:

“Even if a drug is considered similar, it should be easily identified. There’s been a longstanding principle in health care that pharmacists have used to avoid look-alike, sound-alike drug names, so the industry’s been asked to change drug names so there aren’t those kinds of mix-ups,” said Philip Schneider, MS, FASHP, Associate Dean at the University of Arizona College of Pharmacy and a member of the international advisory board to the Alliance for Safe Biologic Medicines. “Once a decision is made, it should be very clear what drug the patient’s receiving.”

Read the full article here.

 

Videos Explaining the Biologics and Biosimilars

January 13, 2015

Amgen Canada has created two new videos explaining the differences between biologics and biosimilars. The videos show why manufacturing really matters and the importance of patient safety as biosimilars are approved.

Watch the videos here.

Inside Health Policy: FDA Guidance Agenda Doesn’t List Biosimilar Naming, But Includes Labeling

January 13, 2015

The controversial issue of biosimilar naming is seemingly absent from the FDA drug center’s 2015 guidance agenda as all signs point to the agency approving the first U.S. biosimilar by early March. The guidance agenda slates four biosimilar documents the agency plans to put out this year including one on labeling, but there is no mention of a guidance specifically on the naming issue.

Read the full article here.

December 2014 Newsletter

January 8, 2015

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:

  • January 29-30: CBI 10th Annual Summit on Biosimilars in Alexandria, VA

  • February 23-25: Biosimilars and Follow-on Biologics 2015 Americas in Washington, DC
  • April 13-15: WHO 60th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland  
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