A lot has happened since we last addressed new biosimilar developments in January 2018. In the intervening months, there have been many significant developments related to FDA’s implementation of an efficient regulatory program for biosimilar products and the abbreviated BLA (aBLA) review process. Today we’re going to recap some of what has transpired over the past 5 months in the biosimilars space in an attempt to get our readers caught up. Continue Reading Biosimilars in the Limelight – A Lot Has Happened Since January 2018
It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation’s abbreviated marketing pathway for biosimilar products.
After the Supreme Court issued its first ruling on the BPCIA in June 2017 (see our prior post here), it sent the dispute between Amgen and Sandoz back to the Federal Circuit Court of Appeals to resolve the question of whether Amgen’s claims asserted under California law, including a claim of unfair competition, were preempted under the BPCIA. Continue Reading Biosimilar Market Developments Continue Apace in 2018
On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral arguments on the last day of the Court’s October 2016 Term, as we previously reported. With respect to both of the significant issues presented, the Justices unanimously reversed the Federal Circuit Court of Appeals split opinion and remanded for further consideration of questions related to State law.
Although our intellectual property colleagues have separately analyzed the “Patent Dance” implications of the Court’s decision in Amgen v. Sandoz (see here), the second issue presented in the case related to the proper interpretation of the 180-day notice provision of the Biologics Price Competition and Innovation Act (“BPCIA”). The Federal Circuit had held that such notice by the biosimilar applicant can only be provided to the reference product sponsor after FDA licenses (i.e., approves) the biosimilar application. Continue Reading SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs
We spend a lot of time covering prescription drug costs on this blog (and here), and even convened a Pharmacy Industry Summit earlier this year focusing on the various pressures that are contributing to higher drug prices. Although Congress has not been sitting on the sidelines of the drug pricing debate – having conducted three separate committee investigations, which included subpoenas of top executives and the most well-known of them, Martin Shkreli, getting booted from the committee room for refusing to answer any questions – Members of Congress are finally beginning to roll out legislation with the end goal of increasing prescription drug competition and decreasing the costs of drugs. Continue Reading Congress Proposes Legislative “Fixes” to Drug Industry Rules Believed to Be Contributing to High Costs
In another highly anticipated regulatory move, FDA has released draft guidance on “Labeling for Biosimilar Products.” Made public on March 31st, the draft guidance sets forth FDA’s recommendations on the labeling of biosimilar products that are approved via the abbreviated licensure pathway created in 2010 by the BPCIA. The Agency has been under pressure for many months now to issue some sort of policy on biosimilar labeling, whose contours will have dramatic impacts on the growth and development of this industry in the United States.
Many stakeholders have been critical of last year’s final labeling package for Zarxio (filgrastim-sndz), the first biosimilar approved in the U.S., because that labeling was essentially identical to the labeling for the reference filgrastim product, Amgen’s Neupogen. Biologic manufacturers (such as AbbVie, who in December filed a Citizen Petition with FDA regarding the scope and content of biosimilar labels) have cited concerns that labeling for a biosimilar should not be “the same as” the reference biologic’s label in the same way that generic drug labels are generally the same as their reference listed drug product’s label. These industry stakeholders, along with certain patient and provider groups, argue that biosimilars should not be treated the same as generic drugs because the statutory standard for FDA approval is that a biosimilar be “highly similar” to its reference and have “no clinically meaningful” differences compared to the reference biologic – a different approval standard than what small-molecule generic drugs have under the Hatch-Waxman Act. On the other hand, FDA also received another Citizen Petition late last year that requested generic drug-style labeling for the biosimilar class of products.
Therefore, a key aspect of the newly issued draft guidance is the extent to which biosimilar labeling should be consistent with the label of the reference product. FDA is not requiring biosimilar labels to be identical to its reference product; however, it proposes that biosimilar labels should heavily rely upon their reference products. Specifically, FDA states in the draft guidance: Continue Reading FDA Differentiates Biosimilar Labeling from Generic Drug Labeling
Tuesday, February 9th was a busy day for Korean biologics company Celltrion Inc. The company had its proposed biosimilar CT-P13 before the FDA Arthritis Advisory Committee as well as a hearing in federal court in Massachusetts as part of the patent dispute with the manufacturer of the reference biologic, Remicade (infliximab), Janssen Biotech. At the end of the day, CT-P13 – which would be the first monoclonal antibody approved under the FDA’s biosimilar program – received the support of Arthritis Advisory Committee members. The outcome of yesterday’s hearing in the patent litigation remains unknown. When factual issues are not in dispute, FDA typically follows the advice of its expert advisory committees on approval and/or restrictions on new products, so we expect final approval of the Celltrion product in the coming months. Remicade is a blockbuster drug, with estimates of over $4 billion in sales annually in the U.S. alone, so the anticipated approval of a biosimilar version of infliximab has significance for health care providers, payors, and patients as well as investors. Our colleague Tom Wintner talks more about these developments today on the Global IP Matters Blog, available here.
For further developments in the biosimilars arena tune in to the Mintz Levin biosimilars webinar series (register here), the next installment of which is taking place on February 25 at 3pm ET.
Our Biosimilar webinar series continued this month with Linda Bentley and Joanne Hawana’s Biosimilars FDA/Regulatory Overview presentation. Linda and Joanne discussed statutory provisions related to FDA’s authority to approve biosimilar products, as well as FDA guidance on demonstrating biosimilarity, biosimilar product development and user fees, “interchangeable” biosimilars, biosimilar product labeling and naming, and reference product and biosimilar exclusivity.
For those who missed the webinar, some of the key takeaways include the following: Continue Reading ICYMI: Biosimilars and FDA Regulatory Webinar
Mintz Levin is running a series of webinars to educate our clients and friends on developments in the biosimilars space. A cross-practice team of professionals from the IP, Health and Litigation sections are collaborating to present on Patent Prosecution, Health Regulatory, FDA, Patent Litigation, Transactional and Products Liability issues. Anyone working in the biotechnology space, as well as pharmacy payors and health care providers who may be administering or dispensing biosimilars to their patients, will be interested in these presentations. The first webinar on January 7, 2016 will provide a legal and regulatory overview of the biosimilars industry and will feature Terri Shieh-Newton, PhD, and Joanne Hawana.
Part II: FDA/Regulatory — January 28 | 3:00 pm ET
Part III: BPCIA Patent Litigation — February 25 | 3:00 pm ET
Part IV: Transactions and Patent Portfolios — March 17 | 3:00 pm ET
Part V: Post-Market Legal and Regulatory Issues — April 7 | 3:00 pm ET
Looking back on 2015, it’s apparent that this was another very busy year for the Food and Drug Administration (FDA or Agency), whose oversight responsibilities are estimated to touch 25% of American consumers’ spending on various regulated products. There was no shortage of significant Agency actions in 2015 related to therapeutic and diagnostic products, which include traditional chemical drugs, biological products, medical devices and diagnostic tests, and even stem cell therapies and human tissue products. Also noteworthy is that FDA is reporting that as of December 14th it had granted approval to 42 groundbreaking new drugs (called “new molecular entities” or NMEs) and therapeutic biological products during the calendar year. The figure so far for this year beats 2014’s final count of 41 approved NMEs and far exceeds the prior year’s total of 27 NMEs. This post will highlight some of FDA’s significant actions this year and provide our thoughts about what next year may bring for FDA-regulated entities.
Continue Reading FDA Legal and Regulatory – 2015 Year In Review
With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. This past year saw significant changes in the pharmacy industry. From multiple high-profile mergers changing the PBM landscape, to the recent controversy over drug pricing, the pharmacy industry was in the national spotlight for much of 2015. Meanwhile, federal and state enforcement continued to focus on pharmaceutical manufacturers, PBMs, and pharmacies. We also saw the first biosimilar approval in 2015, significant updates to the 340B program, an increased focus on value-based purchasing, and additional state legislation focusing on PBMs.
Industry Consolidation – Changing PBM and Payor Landscape
There was a significant wave of merger activity in the PBM and payor industry in 2015, with pharmacy chains acquiring PBMs and long term pharmacies, as well as mergers among some of the largest payors. This consolidation has reshaped the traditional PBM industry paradigms with a move away from stand alone PBMs to payor and provider affiliated PBMs. This consolidation and alignment with payors and providers has been driven by a need to increase negotiating power and create economies of scale in the face of rising drug costs and fewer drug discount opportunities. In addition, PBMs and payors are looking to adapt to new forms of payment encourage by the Affordable Care Act. The Affordable Care Act has spurred CMS and private payors to focus on value-based purchasing and pricing. Entities with integrated payor and provider operations (including expanded access to data critical for analytics) may be in a better position to save costs and compete in the market.
Moving into 2016, it is unclear if this merger frenzy will continue and if we will see additional consolidation among some of the stand-alone PBMs. Nonetheless, this increased merger activity may lead to more competitive pricing and negotiating power among PBMs, as well as a new focus on the use of contract terms with performance based results. Continue Reading The Pharmacy Industry – 2015 Year In Review