Posts – Page 4 – Safe Biologics

ASBM Exhibits at ACR Convergence 2023

December 1, 2023

From November 12-14, ASBM exhibited at Booth #2612 at ACR Convergence 2023 in San Diego, CA. ACR Convergence is hosted annually by the American College of Rheumatology and is considered the premier meeting for rheumatology professionals globally. ASBM was represented at the booth by Executive Director Michael Reilly, Advisory Board Chair Philip Schneider, and Programs Director Ray Patnaude. Visitors to the booth learned about ASBM’s recent educational activities surrounding IRA Medicare drug price negotiation, interchangeable biosimilars, and other key policy issues affecting patient access to medicines.

Learn more about ACR Convergence 2023 here.

ASBM Releases Fact Sheets on Interchangeable Biosimilars

November 30, 2023

In November, ASBM released two fact sheets on interchangeable biosimilars. Download them here:

Physician Perspectives on Interchangeable Biosimilars

Interchangeable Biosimilars: Comparing Europe and the U.S.

September 2023 Newsletter

November 12, 2023

ASBM Whitepaper to Examine Impact of Medicare Drug Price-Setting on Drug Development, Patient Access
The Journal of the Generics and Biosimilars Initiative (GaBI) is currently finalizing a whitepaper based on the July 26th webinar hosted by ASBM and GaBI entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines.  View the full webinar here or watch individual segments linked below. Medicare Part D Experts Discuss Likely IRA Effects Michael S Reilly, Esq; Executive Director, ASBM
Thomas R Barker, Esq; Former Acting General Counsel of the US Department of Health and Human Services; Former Commissioner of the Medicaid and CHIP Payment and Access Commission (MACPAC)
Charles Clapton, Vice President of Federal Government Affairs, Gilead Sciences Drug Developer Discusses Impacts on R&D – Steven Potts, PhD, MBA Innovation and Patient Access – Andrew Spiegel, Esq; Executive Director, Global Colon Cancer Association
Panel Discussion
The article will appear in the next issue of GaBI Journal.

ASBM Letter to Congress Defends Interchangeability Standard In a letter to Senator Mike Lee (R-UT) dated September 27th, ASBM urged the Senator to reconsider his support for S.6 “The Biosimilar Red Tape Elimination Act”, which would prevent the HHS Secretary from requiring switching studies in order for a biosimilar to be deemed “interchangeable”. Under U.S. state law, only interchangeable biosimilars are substitutable at the pharmacy without physician involvement- referred to as “automatic substitution”, due to their having provided additional safety and efficacy data to the FDA demonstrating the same effects can be expected even after repeated switches between biosimilar and reference product. In the letter, ASBM Executive Director Michael Reilly stresses the importance of this data to physicians: Physicians and patients worldwide value data, including switching studies. Surveys of Canadian physicians found that 82% wanted switching studies before automatic substitution was permitted. The figure was nearly identical, 81%, when I shared Australian physician survey findings with officials in their Department of Health, who expressed admiration for the FDA’s interchangeability standard in providing such assurances.
However, S.6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. This would inappropriately limit the FDA’s authority to determine what data is scientifically appropriate for a particular biosimilar to provide in order to receive the designation. The FDA has thus far exercised its flexibility in making these determinations and should be allowed to continue to do so.The interchangeable designation has not only boosted physician and patient confidence, it has done so without becoming a barrier to biosimilar uptake and savings.
In conclusion, weakening the interchangeability standard is an unnecessary and potentially harmful step. By limiting the type of data the FDA can consider when determining suitability for automatic substitution it risks undermining the data-driven confidence physicians and patients have developed in interchangeables. Read the full letter here.

FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars- Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. Under U.S. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber. This is due to their having provided additional data to the FDA, demonstrating that the same result can be expected even after repeated switching with the original biologic.The agency has approved 42 biosimilar products, including four interchangeable biosimilars.  ASBM surveys of U.S. physicians (n=400) and pharmacists (n=401) revealed the value of the interchangeability statement to healthcare providers, with 85% of physicians and 88% of pharmacists rating this information (a statement of whether or not a biosimilar is interchangeable with its reference product) as highly important to appear in the product label/package insert.
A 2021 ASBM multi-specialty physician survey (n=401) revealed the value of the interchangeable designation to prescribers specifically:57% said a biosimilar carrying an interchangeable designation would make them more likely to prescribe it.
59% said that an interchangeability designation makes them more comfortable with a pharmacy-level substitution of a biosimilar in place of the originator.The FDA will be accepting comments on the draft guidance through Nov. 17th. Comments may be submitted here.  ASBM and its member organizations intend to submit comments opposing this move and emphasizing the value this information provides to patients and physicians. Read the new FDA’ Guidance here.
Submit comments on the guidance here.

ASBM to Present at World Drug Safety Congress Americas 2023

On October 19th, ASBM Advisory Board Chair Philip Schneider will present at the World Drug Safety Congress Americas 2023 in Boston, Massachusetts. Dr. Schneider’s presentation is entitled “Preventability and Severity Assessment in Reporting Adverse Drug Reactions: Balancing Effectiveness, Safety and the Responsible Use of Limited Healthcare Resources”. The World Drug Safety Congress Americas will bring together more than 1,300 top leaders and stakeholders in biopharma to discuss the key challenges they are facing in pharmacovigilance and device safety. Participants will explore strategies in data management & signal detection, showcase how AI & machine learning have improved PV processes, and discuss the challenges creating a PV strategy for advanced therapies. Learn more about the Congress here.

ASBM’s Schneider to Discuss Interchangeable Biosimilars at Summit on Biologics On November 2nd, ASBM Advisory Board Chair Philip Schneider will participate in the opening panel discussion at the 8th Annual National Policy & Advocacy Summit on Biologics. The panel is entitled The Evolving Biologics Landscape and will examine the biosimilar marketplace- what has happened in the last year, the impact of adalimumab biosimilars, and what’s next. Other panelists include rheumatologist Angus Worthing, MD; and Amgen’s Leah Christl, PhD; former Director of the Therapeutic Biologics & Biosimilars Staff at the FDA. The event will convene patients, providers, policymakers and advocates to discuss a number of topics impacting the health care space and will be held at the Mayflower Hotel in Washington D.C. from 9:30 am – 2:00 pm ET. Register for the 2023 National Policy & Advocacy Summit on Biologics here.

FDA Approves First Tocilizumab Biosimilar On September 29th, the FDA approved Tofidence (tocilizumab-bavi) as biosimilar to Actemra (tocilizumab). The product is an interleukin-6 (IL-6) receptor antagonist that targets specific inflammatory proteins to suppress the immune system. It is administered via intravenous infusion. Tofidence is approved for the following indications: rheumatoid arthritis in adults, polyarticular juvenile idiopathic arthritis ages 2 and older, and systemic juvenile idiopathic arthritis ages 2 and older. This is the first biosimilar approved to treat systemic juvenile idiopathic arthritis, and the 43rd biosimilar approved by the FDA since 2015.
Read more about the approval here.

Peter J. Pitts: The IRA makes the risks of developing new drugs too high
On September 14th, an op-ed by former FDA Associate Commissioner Peter J. Pitts ran in the Pittsburgh Post-Gazette, in which he highlighted his concerns with Medicare drug price-setting policies stemming from the Inflation Reduction Act (IRA), passed last year. While the law’s price controls on prescription drugs haven’t taken effect yet, but they’re already causing companies to pause research and development efforts, Pitts explains. This is particularly bad for patients with rare diseases: Shortly after the law was signed, biotech firm Alnylam halted development of a drug targeting Stargardt disease, a rare genetic condition that causes vision loss. The company cited the IRA’s poorly designed exemption scheme for “orphan” drugs that treat rare conditions. The medicine was already approved to treat a different rare disease that causes nerve damage, and if the FDA had approved the drug for the additional use, vutrisiran could have lost its orphan status and been subject to price controls. Consider how these perverse incentives could prevent the development of the next Keytruda, the Merck miracle drug perhaps best known for helping former President Jimmy Carter beat cancer. First approved in 2014 to treat one condition, melanoma, Merck now lists 19 separate conditions it can treat — a massive boon for desperate patients. Thanks to the IRA’s price controls, medical marvels like Keytruda will now be even more difficult to achieve. Financing additional research and development into existing treatments will be difficult to justify. Read the full op-ed here. View ASBM’s recent webinar on the IRA’s effects here.

Missed last month’s ASBM Newsletter?Read it here.

UPCOMING EVENTS WHO 77th INN ConsultationGeneva, Switzerland – October 17, 2023
World Drug Safety Congress AmericasBoston, MA – October 18-19, 2023 BIO Patient & Health Advocacy Summit
Washington, DC – October 22-24, 2023 National Policy & Advocacy Summit on Biologics
Washington, DC – November 2, 2023 ACR Convergence 2023
San Diego, CA – November 10-15, 2023

In Shocking Reversal, CMS Wants to Allow Medicare Part D Plan Sponsors to Substitute Non-Interchangeable Biosimilars

November 12, 2023

On November 6, 2023, the Centers for Medicare and Medicaid Services (CMS) announced a proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions such as rheumatoid arthritis, Crohn’s disease and cancer. The policy change represents a stark departure from the perspectives of the U.S. medical community and patient advocacy organizations, a decade of state-level policymaking, and CMS’ recent assurances, warns the Alliance for Safe Biologic Medicines.

“Substitution of biosimilars by someone other than the prescribing physician is a controversial practice banned in many countries, including nearly all of Western Europe”, says ASBM Executive Director Michael Reilly, who served as Associate Deputy Secretary of Health and Services during the development and implementation of the Part D prescription drug benefit. “It is also opposed by the majority of physicians, in the U.S. and worldwide.”

A 2021 survey of 401 U.S physicians found that while 89% of U.S. prescribers have high confidence in the safety and efficacy of biosimilars, a majority (58%) oppose third-party switching of a patient’s biologic medicine for non-medical (e.g. cost, coverage) reasons- as would occur under the proposed CMS rule. Further, 69% consider it very important or critical that physicians, with their patient, make these treatment decisions.

“Treatment plans aren’t one-size fits all”, explains ASBM Chairman and practicing gastroenterologist Ralph McKibbin, MD, FACP, FACG, AGAF. “Patients often try several products over years before finding the one that best stabilizes their condition. As doctors and patients, we’re reluctant to switch a patient’s medicine unnecessarily and risk losing those gains.”

U.S. state laws nationwide permit pharmacy-level substitution of “interchangeable biosimilars”- those for which the manufacturer has provided additional safety and efficacy data to the FDA showing that a patient who’s been switched to the interchangeable product will have the same results as staying on the originator product. These laws were passed state by state over the past decade with the support of physician societies and patient advocacy organizations- contingent on assurances that only interchangeable biosimilars would ever be substituted without physician approval.

The additional data the interchangeable biosimilar carries dramatically boosts physician confidence: most (57%) said they would be more comfortable prescribing an interchangeable, and most (59%) are more comfortable with it being substituted in place of the prescribed originator product. Seven of the 44 FDA-approved biosimilars are interchangeable.

The dramatic change in policy proposed by CMS comes less than a year after a CMS Rule permitting Part D plan sponsors to substitute interchangeable biosimilars explicitly reassured the public it would not permit substitution of non-interchangeable biosimilars because they “have not met the requirements to support a demonstration of interchangeability.”

“Nothing has changed regarding non-interchangeable biosimilars since last year’s CMS Rule,” says Reilly. “Non-interchangeables still haven’t met the FDA data requirements for interchangeability and still shouldn’t be substituted by a third party without physician approval. This ill-considered move stands in stark contrast to the opinions of the medical community, the wishes of patients, a decade of substitution policymaking across 50 states, the substitution policies of most advanced nations, and CMS’ own assurances. We respectfully urge CMS to reconsider and withdraw this rule.”

For more information on interchangeable biosimilars, Reilly directs the public to several ASBM resources on the topic including a recent podcast, a letter to Congress supporting the standard, a video on physician perspectives, and an educational backgrounder.

ASBM is an organization of physician, patient advocates, pharmacists, and manufacturers of both biologic medicines and biosimilars. Since 2010, ASBM has worked to keep patients at the center of health policymaking. Learn more at www.safebiologics.org. Contact:media@safebiologics.org

View a PDF of this statement https://safebiologics.org/wp-content/uploads/2023/11/CMS-NICBS-STMT-FNL-1.pdfhere.

August 2023 Newsletter

October 10, 2023

ASBM Statement on Announcement of Medicare Drug Price-Setting List

On August 29th, the Centers for Medicare & Medicaid Services (CMS) announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed into law last year. Over the next 4 years, Medicare will set prices for up to 60 drugs covered under Medicare Part D and Part B.This shortsighted move won’t control costs and threatens to limit patient access to new medicines, ultimately resulting in worse health outcomes for U.S. patients, warns ASBM in a statement:

IRA Changes Break a Successful Program
Michael Reilly, ASBM Executive Director and former Associate Deputy Secretary in the U.S. Department of Health and Human Services, worked on the development and implementation of the Part D prescription drug benefit during his six years in the Secretary’s Office. While proponents of government price-setting in Medicare claim this will create savings and lower costs, Reilly disagrees:“Part D was designed following two decades of experience seeing government price-setting fail to control Medicare costs for services and healthcare provider rates. To avoid this happening with the new prescription drug benefit, we created a new model. Contrary to what many believe, under Part D, drug price negotiations do occur- they are conducted by pharmacy benefit managers (PBMs), and the law specifically forbid government interference in price-setting or formulary selection. As we intended, this approach has been incredibly successful in controlling costs: the Congressional Budget Office projected drug spending between 2004-2013 to be $770 billion; actual expenses were 45% lower- at $421 billion. It has a 90% approval rating among beneficiaries, premiums have held steady around $32/month since 2006, and it holds the distinction of being the only major federal program to ever come in under budget.”

A Better Reform: Ensuring Savings Are Passed Onto Patients
While price-setting proponents say beneficiaries will start to see lower drug prices beginning in 2026, there’s no evidence that this is true, and there are better ways to lower out-of-pocket costs- and much faster, Reilly explains. “Part D has been hugely successful in lowering costs- but these savings are not always being passed on to the patient by the PBMs. Thankfully, there is a broad bipartisan effort underway in Congress to rectify this and provide immediate relief for patients- this year, not in 2026.” No fewer than eight bills have been introduced or advanced out of committee this session, with bipartisan support, to address PBM rebate and pricing policies that result in higher drug prices for patients.

The Consequences of European-style Drug Price-Setting Policies
Not only will it fail to control costs, imposing European-style price controls on Medicare Part D will spell disaster for American patients in the coming years. Reilly remarks, “The U.S. leads the world in drug innovation and patient access precisely because we’ve rejected the kind of price controls that stifle R&D and delay drug availability in Europe and Asia.” For example:In the 1970s, European companies developed most new drugs; however, since the implementation of price controls in Europe, U.S. companies now produce 60% of new drugs, while European countries often have percentages in the single digits.90% of new cancer drugs are available in the U.S. within the first year, whereas fewer than half are available to cancer patients in Germany, the UK, France, and CanadaEuropean cancer death rates are 1.7 times higher than in the U.S.Reilly describes what European-style health outcomes might look like in the U.S: “Imagine if the U.S. had European cancer death rates. That would translate to an extra 420,000 cancer deaths annually. Europe’s drug price-setting is simply not a policy worth emulating, and American patients should be aware of its public health consequences.”Read the full ASBM Statement here.Read Axios coverage of the announcement here.

FDA Approves First U.S. Biosimilar for Multiple Sclerosis (MS)
On August 25th, the FDA announced approval of Tyruko (natalizumab-sztn) the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). The biosimilar, like its reference product, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α (tumor necrosis factor, a substance in your body that causes inflammation). “Today’s approval of the first biosimilar product indicated to treat relapsing forms of multiple sclerosis furthers the FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost,” said Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research. Tyruko (natalizumab-sztn) is the 42nd biosimilar approved by the U.S. FDA. Read more about the approval here.

Eight Bipartisan Congressional Bills Seek to Regulate PBMs
As of August 25, 2023, no fewer that eight bipartisan bills have been introduced or advanced out of Congressional committees that would restrict or change the practices of Pharmacy Benefit Managers (PBMs). As reported in Health Affairs, the bills focus mostly onfive key areas of PBM activities:TransparencySpread PricingRebatesOut-of-Pocket CostsPart DThe next step for many of the proposed bills is CBO evaluation of each of the bills and these proposals. These assessments will allow legislators to understand whether the new bills are projected to increase or decrease costs, and will likely help to determine eventual passage. Read the Health Affairs coverage of the bills here.

Pill Penalty Will Devastate Cancer Research
Writing in the Hartford Courant August 15th, Kenneth E. Thorpe warns of the devastating effects the Inflation Reduction Act’s “small-molecule penalty” will have on cancer research.Thorpe is Chair of the Department of Health Policy and Management at Emory University.

The small molecule penalty is forcing companies to pivot away from these sorts of breakthroughs — medicines that might otherwise have cut the cancer death rate and advanced the Cancer Moonshot. The CEO of Novartis, for instance, recently announced the company was nixing some cancer medications from its pipeline because it no longer made financial sense to pursue them post-IRA. Some are sounding alarms about the pill penalty’s impact on post-approval research. Oftentimes, companies find that an existing medication can treat another form of cancer years down the road. But successes like those require additional research, which can be costly. And many firms are realizing that, with only nine years to turn a profit, the math no longer adds up. Without a legislative fix, the IRA will be the Achilles heel of the critically important Cancer Moonshot. Luckily, that fix is relatively simple. Congress must afford small molecule drugs the same 13-year protection as biologics. Read the full article here. For more information about the IRA’s harmful effects on drug research and patient access to medicines, visit IRAPatientInfo.org

IRAPatientInfo.org is a central online educational resource containing news articles, infographics, videos, webinars, and other materials patients can use to learn about this policy’s likely effects on innovation and patient access.

Pharmacy Benefit Manager CVS Health Launches Biosimilar Subsidiary
On August 23rd, CVS Health announced the creation of a wholly-owned subsidiary tasked with commercializing and co-producing biosimilars. The new company, called Cordavis, has already contracted with manufacturer Sandoz to market Hymiroz (adalimbumab-adaz) at an 80% discount to its originator product, beginning in Q1 2024.

CVS Health’s chief financial officer Shawn Guertin said: “Cordavis is a logical evolution for us and will help ensure sufficient supply of biosimilars in the US and support this market now and in the future while ultimately improving health outcomes and reducing costs for consumers.” The announcement comes as Congress and the Federal Trade Commission have been investigating the role of PBMs in rising medication costs. Read the announcement from CVS Health here.

Read more about the announcement here.

ASBM Experts Discuss Interchangeable Biosimilars on AI Arthritis Podcast
On August 6th, AI Arthritis released Episode 88 of its AI Arthritis 360 Talk Show, in which ASBM representatives discuss potential policy changes regarding interchangeable biosimilars and how they may undermine the patient protections currently in place. Joining AI Arthritis Executive Director and host Tiffany Westrich-Robertson were ASBM Executive Director Michael Reilly, ASBM Chairman Ralph McKibbin MD FACP FACG AGAF, and ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association.

A biosimilar standard unique to the U.S., an interchangeable biosimilar has provided additional data to the FDA which demonstrate that not only is the product safe and effective, but that any given patient can be repeatedly switched between it and the reference product and expect the same result, without additional risks. Under U.S. state law, only interchangeable biosimilars may be automatically substituted at the pharmacy level without physician involvement.
Listen to the podcast (audio file) Watch the podcast discussion (video file)

Missed last month’s ASBM Newsletter?Read it here.

UPCOMING EVENTS WHO 77th INN Consultation
Geneva, Switzerland – October 17, 2023
World Drug Safety Congress AmericasBoston, MA – October 18-19, 2023ACR Convergence 2023
San Diego, CA – November 10-14

ASBM Letter to Congress Defends Interchangeability Standard

September 27, 2023

In a letter to Senator Mike Lee (R-UT) dated September 27th, ASBM urged the Senator to reconsider his support for S.6 “The Biosimilar Red Tape Elimination Act”, which would prevent the HHS Secretary from requiring switching studies in order for a biosimilar to be deemed “interchangeable”. Under U.S. state law, only interchangeable biosimilars are substitutable at the pharmacy without physician involvement- referred to “automatic substitution”, due to their having provided additional safety and efficacy data to the FDA demonstrating the same effects can be expected even after repeated switches between biosimilar and reference product.

In the letter, ASBM Executive Director Michael Reilly stresses the importance of this data to physicians:

Physicians and patients worldwide value data, including switching studies. Surveys of Canadian physicians found that 82% wanted switching studies before automatic substitution was permitted. The figure was nearly identical, 81%, when I shared Australian physician survey findings with officials in their Department of Health, who expressed admiration for the FDA’s interchangeability standard in providing such assurances.

However, S.6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. This would inappropriately limit the FDA’s authority to determine what data is scientifically appropriate for a particular biosimilar to provide in order to receive the designation. The FDA has thus far exercised its flexibility in making these determinations and should be allowed to continue to do so.

The interchangeable designation has not only boosted physician and patient confidence, it has done so without becoming a barrier to biosimilar uptake and savings.

European biosimilar uptake varies by country and product but hovers within the 20-80% range. Similarly, in the U.S. filgrastim, trastuzumab, and bevacizumab biosimilars have an uptake rate of 80%. Rituximab biosimilars stand at 60% and infliximab, pegfilgrastim, and erythropoietin-stimulating agent (ESA) biosimilars have 40% market share. U.S. biosimilars have generated $21 Billion in savings in the past six years alone.

In conclusion, weakening the interchangeability standard is an unnecessary and potentially harmful step. By limiting the type of data the FDA can consider when determining suitability for automatic substitution it risks undermining the data-driven confidence physicians and patients have developed in interchangeables.

Read the full letter here.

July 2023 Newsletter

September 12, 2023

ASBM & GaBI Webinar on Medicare Price Negotiation Examines Impact on Innovation, Patient Access
On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines. The webinar focused on the IRA’s price negotiation provisions, which grant new authority to the Centers for Medicare and Medicaid Services to negotiate prices of certain costly drugs, including many biologic medicines. Presenters discussed the likely impacts of the legislation, as well as examining the effects government drug price-setting policies in different countries have had on patients.

View the full webinar here or watch individual segments linked below. Medicare Part D Experts Discuss Likely IRA EffectsThree speakers who were deeply involved in the development and implementation of Medicare Part D, the program’s prescription drug benefit, discussed how it will be affected by the IRA changes. These speakers included:Thomas R Barker, Esq; Former Acting General Counsel of the US Department of Health and Human Services; Former Commissioner of the Medicaid and CHIP Payment and Access Commission (MACPAC)
Charles Clapton,Vice President, Federal Government Affairs, Gilead Sciences; former Health Policy Director for the Senate HELP Committee and Former Chief Counsel for the House Ways and Means and Energy and Commerce Committees.
Michael S Reilly, Esq; Executive Director, Alliance for Safe Biologic Medicines; former Associate Deputy Secretary at the U.S. Department of Health and Human ServicesView Mr. Reilly, Mr. Barker, and Mr. Clapton’s segment here.
Drug Developer Discusses Impacts on R&D
Steven Potts, PhD, MBA; CEO of Anticipate Bioscience is a cancer drug developer. Dr. Potts discussed how the IRA will reduce investment in drug research and development, particularly for small molecule drugs.
View Mr. Potts’ segment here. Innovation and Patient Access Andrew Spiegel, Esq; Executive Director of the Global Colon Cancer Association, shared the patient perspective and highlighted the lifesaving value of innovation through personal stories of cancer patients.

View Mr. Spiegel’s segment here.  Other presenters included:Matias Olsen; Public Affairs & Policy Manager, EUCOPE, Belgium Philip Schneider, FASHP, FFIP Past Vice President, International Pharmaceutical Federation (FIP) The event concluded with a panel discussion and Q&A.

View the panel discussion here.

ASBM Launches Microsite on Medicare Drug Price Negotiation

On July 26th, ASBM launched IRAPatientInfo.org, a microsite dedicated to educating patients, healthcare professionals, and the general public about the Inflation Reduction Act (IRA)’s harmful impacts on drug development and research, as well as the likelihood of reduced patient access to lifesaving medicines.

Visit IRAPatientInfo.org IRAPatientInfo.org is a central online educational resource containing news articles, infographics, videos, webinars, and other materials patients can use to learn about this policy’s likely effects on innovation and patient access. Check back frequently, as ASBM will continue to update the site as new articles and additional resources become available.

ASBM Discusses Importance of the Interchangeable Biosimilar Designation on Ai Arthritis Podcast On June 28th, ASBM recorded an episode of the AI Arthritis 360 Talk Showdevoted entirely to the issue of interchangeable biosimilars and how new policies may undermine the patient protections currently in place.

A biosimilar standard unique to the U.S., an interchangeable biosimilar has provided additional data to the FDA which demonstrate that not only is the product safe and effective, but that any given patient can be repeatedly switched between it and the reference product and expect the same result, without additional risks. Listen the the podcast (audio file) Joining Ai Arthritis Executive Director and host Tiffany Westrich-Robertson were ASBM Executive Director Michael Reilly, ASBM Chairman Ralph McKibbin MD FACP FACG AGAF, and ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association. Watch the podcast discussion (video file) Under U.S. state law, only interchangeable biosimilars may be automatically substituted at the pharmacy level without physician involvement.
The panel examines recent statements and legislation which threaten to undermine the interchangeable designation in different ways, and discuss how patients and physicians can help preserve the protections it offers patients.

Senate HELP Bill Would Declare All Biosimilars Interchangeable
In early September, the Senate Committee on Health, Education, Labor, and Pensions (HELP) will begin markup on the Primary Care and Health Workforce Expansion Act, a bill aimed at relieving a shortage of healthcare workers. Buried within this bill however, is a provision which would declare all biosimilars to be “interchangeable”, effectively rendering meaningless the interchangeable biosimilar designation as set forth by the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and nearly a decade of FDA Guidance. Were this provision to pass, it would undo more than a decade of hard-won progress in building physician and patient confidence in the safety and efficacy of biosimilar medicines. As intended, the interchangeable biosimilar designation has built physician and patient confidence as price competition has generated substantial savings to our health system. A 2021 survey revealed that while 89% of U.S. prescribers have high confidence in the safety and efficacy of biosimilars, a majority (58%) oppose third-party switching of a patient’s biologic medicine for non-medical (e.g. cost, coverage) reasons. Yet the interchangeable biosimilar designation has proven successful in promoting confidence in automatic and third-party substitution among a majority of physicians: 57% said they’d be more likely to prescribe an interchangeable biosimilar; 59% said that an interchangeability designation makes them more comfortable with a pharmacy-level substitution of a biosimilar in place of the originator.
Weakening the interchangeable biosimilar standard by applying it to all biosimilars -including those which have not provided additional data- would have immediate and harmful effects nationwide. Beginning in 2013, all 50 states and Puerto Rico enacted legislation that allows for automatic substitution of interchangeable biosimilars at the pharmacy level without the need for physician involvement or approval. Automatic substitution of biosimilars is highly controversial among physicians for the reasons mentioned, and is banned in many countries including most of Europe. The U.S. laws were passed with the support of state medical and pharmacy societies as well as national and state patient advocacy organization, contingent on the understanding and expectation that only interchangeable biosimilars—those that have demonstrated safe switching through additional data provided to the FDA—would ever be substituted without physician involvement. ASBM will continue to monitor the progress of this legislation.

Missed last month’s ASBM Newsletter?Read it here.

Medicare Price “Negotiations” Will Jeopardize Patient Access to New Medicines, Result in Worse Health Outcomes

September 11, 2023

The Centers for Medicare & Medicaid Services (CMS) recently announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed in to law last year. Over the next 4 years, Medicare will set prices for up to 60 drugs covered under Medicare Part D and Part B. This shortsighted move won’t control costs and threatens to limit patient access to new medicines, ultimately resulting in worse health outcomes for U.S. patients, warns ASBM.

IRA Changes Break a Successful Program
Michael Reilly, ASBM Executive Director and former Associate Deputy Secretary in the U.S. Department of Health and Human Services, worked on the development and implementation of the Part D prescription drug benefit during his six years in the Secretary’s Office. While proponents of government price-setting in Medicare claim this will create savings and lower costs, Reilly disagrees:

“Part D was designed following two decades of experience seeing government price-setting fail to control Medicare costs for services and healthcare provider rates. To avoid this happening with the new prescription drug benefit, we created a new model. Contrary to what many believe, under Part D, drug price negotiations do occur- they are conducted by pharmacy benefit managers (PBMs), and the law specifically forbid government interference in price-setting or formulary selection. As we intended, this approach has been incredibly successful in controlling costs: the Congressional Budget Office projected drug spending between 2004-2013 to be $770 billion; actual expenses were 45% lower- at $421 billion. It has a 90% approval rating among beneficiaries^[1], premiums have held steady around $32/month since 2006, and it holds the distinction of being the only major federal program to ever come in under budget.”

A Better Reform: Ensuring Savings Are Passed Onto Patients
While price-setting proponents say beneficiaries will start to see lower drug prices beginning in 2026, there’s no evidence that this is true, and there are better ways to lower out-of-pocket costs- and much faster, Reilly explains. “Part D has been hugely successful in lowering costs- but these savings are not always being passed on to the patient by the PBMs. Thankfully, there is a broad bipartisan effort underway in Congress to rectify this and provide immediate relief for patients- this year, not in 2026.” No fewer than eight bills have been introduced or advanced out of committee this session, with bipartisan support, to address PBM rebate and pricing policies that result in higher drug prices for patients.

The Consequences of European-style Drug Price-Setting Policies

Not only will it fail to control costs, imposing European-style price controls on Medicare Part D will spell disaster for American patients in the coming years. Reilly remarks, “The U.S. leads the world in drug innovation and patient access precisely because we’ve rejected the kind of price controls that stifle R&D and delay drug availability in Europe and Asia.” For example:

In the 1970s, European companies developed most new drugs; however, since the implementation of price controls in Europe, U.S. companies now produce 60% of new drugs, while European countries often have percentages in the single digits.^[1]
90% of new cancer drugs are available in the U.S. within the first year, whereas fewer than half are available to cancer patients in Germany, the UK, France, and Canada^[2]
European cancer death rates are 1.7 times higher than in the U.S.^[3]

Reilly describes what European-style health outcomes might look like in the U.S: “Imagine if the U.S. had European cancer death rates. That would translate to an extra 420,000 cancer deaths annually. Europe’s drug price-setting is simply not a policy worth emulating, and American patients should be aware of its public health consequences.”

ASBM Leading Education Efforts
ASBM has submitted comments to CMS critical of the policy and is conducting an educational campaign about the policy’s harmful effects. On July 26^th, ASBM hosted a webinar with the Generics and Biosimilars Initiative (GaBI) to examine the price-setting policy’s impact on drug development and reduced patient access to new medicines. The event featured three former government officials who were instrumental in the development of Medicare Part D’s prescription drug benefit; as well as experts from the fields of cancer drug research and patient advocacy, each of whom voiced their strong concerns with the policy individually and in a panel discussion.

ASBM also maintains an educational microsite for the patient community at IRAPatientInfo.org

The Alliance for Safe Biologic Medicines (ASBM) is a diverse group of stakeholders that includes physicians, pharmacists, patient advocates, researchers, and biopharmaceutical manufacturers. Since 2010, ASBM has worked closely with regulators worldwide as they develop and implement health policies, to ensure that these reflect the best interests of patients.

^[1] “Europe negotiates a poor vaccine rollout”; Forbes, April 2021

^[2] IQVIA Analytics, FDA, EMA, PMDA, TGA, & Health Canada data, April 2021.

^[3] “Democrat plan on drug costs will stifle innovation”, San Antonio Express-News, May 12, 2021

^{^[1]} https://www.usatoday.com/story/onpolitics/2012/10/03/poll-medicare-prescription-drug-program-popular/1609995/

ASBM Experts Discuss Interchangeable Biosimilars on AI Arthritis Podcast

September 6, 2023

On September 6th, AI Arthritis released Episode 88 of its AI Arthritis 360 Talk Show, in which ASBM representatives discuss potential policy changes regarding interchangeable biosimilars and how they may undermine the patient protections currently in place. Joining AI Arthritis Executive Director and host Tiffany Westrich-Robertson were ASBM Executive Director Michael Reilly, ASBM Chairman Ralph McKibbin MD FACP FACG AGAF, and ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association.

Watch the video file of the discussion

A biosimilar standard unique to the U.S., an interchangeable biosimilar has provided additional data to the FDA which demonstrate that not only is the product safe and effective, but that any given patient can be repeatedly switched between it and the reference product and expect the same result, without additional risks. Under U.S. state law, only interchangeable biosimilars may be automatically substituted at the pharmacy level without physician involvement.

Listen to the podcast (audio file)

Dr. McKibbin Presents Poster Session at DIA Global Annual Meeting 2023

July 20, 2023

On June 26th, ASBM Chairman Ralph McKibbin presented a poster at the DIA Global Annual Meeting in Boston, MA. The poster was based on the findings from ASBM’s Canadian ophthalmologist survey and compared the findings with those of other physicians surveyed in recent years. The surveys examined physician attitudes toward biosimilar substitution practices, pharmacovigilance and nomenclature standards, and different biosimilar access scenarios.

View the poster For example, 81% of ophthalmologists were uncomfortable with a third-party payer (such as a government or private insurer) switching their patient’s biologic medicine for non-medical reasons (e.g. cost or coverage), as occurs under the government health plans of several provinces. 90% believe treatment decisions should rest with the physician and patient, and 91% believe they should be able to prevent a forced switch. Ophthalmologists are the latest group of physicians to raise concerns with the practice of forced switching- which has become increasingly common among Canadian provinces.

Dr. McKibbin presents the poster findings

View Dr. McKibbin’s video walkthrough of the poster Prior ASBM surveys across many specialties revealed that 83% of Canadian, 82% of European, and 69% of U.S. physicians consider it very important or critical that the physician and patient control treatment decisions, including the decision to switch to a biosimilar. 79% of Canadian, 84% of European, and 67% of U.S. physicians considered the ability to prevent a substitution similarly important. View the poster here.

View Dr. McKibbin’s video walkthrough of the poster here.