April 22, 2020
Drug Pipeline for 2020 Strong in Generics, Biosimilars
Specialty Pharmacy Continuum | by Karen Blum | www.specialtypharmacycontinuum.com
The drug pipeline for 2020 appears heavy on generics, biosimilars and 505(b)(2) drugs that are slight variations of existing products, said industry experts during a webinar sponsored by the Academy of Managed Care Pharmacy (AMCP).
Expected Generic Launches
A number of notable generic launches are expected in 2020, said Jeffrey Casberg, MS, RPh, and Leslie Fish, RPh, PharmD, who are both vice presidents of pharmacy for the research organization IPD Analytics.
Generics for emtricitabine and tenofovir disoproxil fumarate (Truvada, Gilead); dimethyl fumarate (Tecfidera, Biogen); dexlansoprazole (Dexilant, Takeda); and fingolimod (Gilenya, Novartis) could drive drug prices down significantly, Dr. Casberg said.
Six potential generic entrants are in the works for the smoking cessation medicine varenicline (Chantix, Pfizer), which is expected to lose patent exclusivity this year, Dr. Fish said. Payors are looking forward to lower-cost options for the widely used drug, with sales of $702 million, she noted.
Nine potential generics could hit the market for fesoterodine (Toviaz, Pfizer), an antispasmodic for the treatment of overactive bladder symptoms, which also is expected to lose patent exclusivity this year. A number of other generics and branded drugs are available to treat the condition, Dr. Fish noted, making this an area ripe for drug utilization management.
505(b)(2)s and Biosimilars in the Pipeline
About a dozen notable 505(b)(2) drugs have been approved or have approvals pending, the speakers said. These include ethinyl estradiol-levonorgestrel (Twirla, Agile), a transdermal birth control system approved in February, and apomorphine (APL-130277, Sunovion), an oral dopamine receptor agonist for the off-periods experienced by patients with Parkinson’s disease, pending approval in May. Given that 40% to 60% of these patients develop off-periods that can worsen and a transdermal product is seen as more convenient than apomorphine injection (Apokyn, U.S. WorldMeds), this product could be used extensively, Dr. Fish said.
This year also should see a number of launches of biosimilars, the speakers predicted. This includes HSP-130 (Hospira/Pfizer) and Rolontis (Hanmi Pharma/Spectrum) for pegfilgrastim, expected between June and October; SB8 (Samsung Bioepis/Merck) for bevacizumab, expected in September; and ABP 798 (Amgen/Allergan) for rituximab, expected in the fourth quarter, Dr. Fish said. They’ll join six approved biosimilars for pegfilgrastim, three for bevacizumab and three for rituximab.
“We believe with this many biosimilars in the market, we will see decreased cost, but the decrease will be seen through increasing rebates and better contracting in both the brand and biosimilar space,” Dr. Fish said.
New Branded Products
The presenters also referenced a number of new branded products that have been approved or are expected to be approved this year. These include bempedoic acid (Nexletol, Esperion) and bempedoic acid-ezetimibe (Nexletol, Esperion), approved as a first-in-class adjunctive therapy for patients requiring addition cholesterol lowering beyond that seen with standard treatments, and inclisiran (Novartis), an experimental subcutaneous PCSK9 inhibitor expected to be approved in the fourth quarter.
The COVID-19 pandemic could have an impact on new drug approvals, Dr. Fish said during a question and answer period. The FDA has been back and forth, saying there would or would not be delays, she noted.
As of April 17, the agency announced that everything coming to near term, especially oncology and orphan medications, and those for serious diseases, will not be delayed, she said. However, several manufacturers have reported they were going to slow down or delay clinical studies because they are shifting gears to work on potential COVID-19 therapies. It’s also difficult now for study participants to get to their physicians for checkups or lab tests, Dr. Fish said. Combined, she said, these factors could result in a larger number of medications being approved in 2021.
April 27, 2020
IPD Analytics Experts Discuss the Insulin Pipeline
Center for Biosimilars | www.centerforbiosimilars.com
CfB: Hello, I'm Matthew Gavidia. Today on MJH Life Sciences News Network, The Center for Biosimilars® is pleased to welcome Dr Leslie Fish, vice president of Clinical Pharmacy for IPD Analytics, and Jeffrey Casberg, vice president of Clinical Pharmacy for IPD Analytics. Can you both introduce yourselves and tell us a little bit about your work?
Casberg: Sure, Jeff Casberg, again, one of the vice presidents of clinical pharmacy at IPD. We service many different constituents in the pharmaceutical landscape: payers, pharma manufacturers, specialty pharmacies, retail pharmacies, etc. I work with these manufacturers and payers to help them interpret formulary management and other aspects of the pharmaceutical landscape such as [what] we're speaking to today on biosimilars.
Fish: Hi, I'm Leslie Fish and I do the same thing that Jeff does. We each take different areas and one of the areas that I actually work with is oncology.
CfB: So, going to the first question, Leslie, can you please tell us about the biosimilars that have been launched already in 2020 and the launches you anticipate for the remainder of the year?
Fish: Sure. I'm going to divide these into 2 questions. And I'm first going to talk about what we're seeing right now currently with biosimilars and then I can actually take question 2, which is, what are we going to be seeing for the rest of the year and what should it look like? So, first of all, on the market, as far as biosimilars for oncology, we have Herceptin [trastuzumab], Avastin [bevacizumab], Rituxan [rituximab], Neulasta [pegfilgrastim], and Neupogen [filgrastim]. Historically, we've seen very slow trends and utilization with the current biosimilar medications we have. see more
April 21, 2020
AMCP Presenters Predict 4 More Biosimilar Launches in 2020
Center for Biosimilars | by Tony Hagen | www.centerforbiosimilars.com
The year 2020 has already seen 4 biosimilar launches in the United States, and those could be augmented by several more, although the coronavirus disease 2019 (COVID-19) pandemic has introduced a wild card to the mix, said presenters at the American Academy of Managed Care Pharmacy eLearning Days virtual meeting.
But the pipeline from 2021 to 2025 is stocked with at least 5 approved biosimilars to adalimumab, and potentially 4 others, all of which could conceivably launch in 2023, and 14 other potential biosmilar products, which could make the next several years a very active growth time for the US biosimilar space, the presenters said.
The pace of clinical trials has also been affected, and with regard to approvals, the FDA’s most recent notice has been that there will be no “near-term” affect on these, said Leslie Fish, RPh, PharmD, who co-presented with Jeffrey Casberg, MS, RPh, in the session, "Drug Pipeline: Traditional Pharmaceuticals and Bisoimilars." Both are experts on the pharmaceutical pipeline with IPD Analytics.
One thing that could happen is that any delays caused by COVID-19 in 2020 could lead to a slew of backlogged approvals or launches in 2021, Fish said.
A lot of companies have stated that they are going to slow their existing studies or hold up new studies of various agents, because they’re now working on COVID-19 therapies or vaccines, she added. see more
April 21, 2020
A Look at the Generic and Biosimilar Drug Pipeline
AMCP | by Kerri Fitzgerald | www.amcp.org
During a presentation at AMCP eLearning Days, Jeffrey Casberg, MS, RPh, and Leslie Fish, RPh, PharmD, both vice president of pharmacy at IPD Analytics, LLC, discussed potential generic and biosimilar drugs coming to market, including projected timelines and implications for managed care pharmacy.
To reduce drug approval time, the U.S. Food and Drug Administration (FDA) has changed policies that speed up medication approvals, including accelerated and expedited reviewers, shorter studies, and use of surrogate markers. However, this often means less data are available about clinical efficacy and side effects at launch and more post-marketing studies are required.
The speakers detailed notable brands losing exclusivity in the near future and what that means for the treatment landscape. In the HIV treatment landscape, Atripla® (efavirenz/emtricitabine/tenofovir disproxil fumarate) will lose exclusivity in September. There are four new potential entrants to the space in 2021 and two in 2029. Truvada® (emtricitabine, tenofovir disoproxil fumarate) will also lose exclusivity in September. A new potential entrant could come this year, with nine potential options in 2021.
In the oncology space, Afinitor® (everolimus) 2.5, 5, and 7.5 mg already have a generic on the market, with four potential other generics in the pipeline. Afinitor® (everolimus) 10 mg has an additional four potential generic options. Zortress® (everolimus) 0.25, 0.5, 0.75, and 1.0 mg have three potential generic options.
Byetta™ (exanitide), a glucagon-like peptide-1 treatment for type 2 diabetes, will lose exclusivity this year, with two potential generic entrants. Dalirsp® (roflumilast) is a phosphodiesterase-4 inhibitor for the treatment of chronic obstructive pulmonary disease that will lose exclusivity this year or in 2021. There are 12 potential new generic entrants. Chantix® (varenicline) for smoking cessation has a loss of exclusivity this year or in 2021, with six potential generic entrants available between this year and 2022.
In March, the approved marketing applications for the small subset of “biologic products” such as insulin and human growth hormone, which for complex historical reasons were previously approved by the FDA as drugs under the new drug application (NDA) process, were deemed to be biologics. A 505(b)(2) is an NDA that has some efficacy and safety information from the applicant but also relies on information that comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.
The speakers then discussed some notable 505(b)(2)s that are pending approval:
Rizaport® (rizatriptan benzoate) for migraine headache
Naloxone nasal spray 8 mg for opioid overdose
Trevyent® (treprostinil) for pulmonary arterial hypertension
Apomorphine, a dopamine receptor agonist for Parkinson’s disease
Celecoxib 56 mg/tramadol 44 mg tablet for severe pain
In addition, several biosimilars are expected to launch this year, including:
HSP-130 (pegfilgrastim) in June
SB8 (bevacizumab) in September
Rolontis (pegfilgrastim) in October
ABP 798 (rituximab) during the fourth quarter
There also appear to be 14 potential biosimilar agents that will launch in the next five years for ranibizumab (Lucentis®), eculizumab (Soliris®), ustekinumab (Stelara®), abatacept (Orencia®), golimumab (Simponi®), and more.
January 23, 2020
Express Scripts Coverage, FDA Label Update Boost Rybelsus
RADAR on Drug Benefits | by Sharon Bender | www.aishealth.com
Access to Novo Nordisk’s Rybelsus (semaglutide)—the first oral glucagon-like peptide-1 receptor agonist (GLP-1) to treat adults with type 2 diabetes—got a major boost January 17th, 2020 when Novo said Express Scripts, part of Cigna Corp., will cover the agent. Rybelsus was approved in September 2019 and is available as a once-daily tablet version of the drugmaker’s Ozempic (semaglutide), a weekly injection launched in 2018.
“We’ve been keeping a keen eye on the new 2020 formulary postings, watching weekly, and monitoring all the big payers’ formularies, and it’s been interesting to note that it looks as though Novo is still in negotiations” for Rybelsus, Jeffrey Casberg, M.S., R.Ph., Director of Clinical Pharmacy at IPD Analytics, told AIS Health. “You would think by now, more often than not you’d see more formularies updated, and we haven’t seen that yet.” IPD provides drug intelligence and consulting to stakeholders across the pharmaceutical landscape.
Casberg represented the payer community on the Institute for Clinical and Economic Review’s (ICER) November policy roundtable panel in which clinical, manufacturer, payer, and patient advocate participants discussed key questions identified by ICER researchers related to oral semaglutide’s cost-effectiveness. A report of the panel’s recommendations, “Oral Semaglutide for Type 2 Diabetes: Final Policy Recommendations,” was published December 9, 2019 along with ICER’s “Oral Semaglutide for Type 2 Diabetes: Effectiveness and Value, Final Evidence Report.” ICER is an independent non-profit research organization. see more
January 10, 2020
Jeff Casberg, RPh, MS Weighs in on Rybelsus
A recent article in the Pink Sheets quoted Jeff on the comments he provided as a panelist at the ICER meeting on Rybelsus.
December 19, 2020
August 12, 2019
Q&A, Part II: How Payers and Providers are Responding to the
The conversation continues around biosimilar management and strategy in Part II of The Advisory Board Company's blog post. In this feature, IPD’s Executive Clinical Pharmacists, Leslie Fish, Pharm D. and Jeffrey Casberg, RPh discuss how payers are responding to the evolving biosimilar market and what providers need to know to make the most of this evolving space.
August 5, 2019
Q&A: What Providers Need to Know About a Changing Biosimilar Market
Two senior members of our Clinical Pharmacy team, Leslie Fish, Pharm D. and Jeffrey Casberg, RPh, recently sat down with the research team at The Advisory Board Company to talk about how the biosimilar market is evolving and why it is critical that health systems develop a cohesive and comprehensive biosimilar strategy.
August 2, 2019
National Trends in Prescription Drug Expenditures and Projections
The cost of prescription drugs continues to be a center of focus for the news media, regulators, payers, providers, manufacturers, and many others across the health care landscape. This important article from AJHP, which leverages IPD’s proprietary data and expert insights on forthcoming approvals from the FDA, addresses some of the critical factors driving these costs.
May 9, 2019
The Institute for Clinical and Economic Review (ICER) Will Now Leverage Data and Insights from IPD Analytics
Bay Harbor Islands, FL – May 9, 2019
The Institute for Clinical and Economic Review (ICER) has reached an agreement with IPD Analytics, LLC (IPD)whereby ICER will leverage IPD’s data, expertise, and assessments to advance their horizon scanning efforts across the pharmaceutical and biologic markets.
ICER is an independent and non-partisan research organization that objectively evaluates the clinical and economic value of prescription drugs, medical tests, and other health care innovations. IPD combines purpose-built data curation mechanisms with an experienced team of uniquely qualified experts to provide deep, informed, and fully independent analysis on the biopharmaceutical industry’s current state and trajectory.
The collaboration involves ICER incorporating IPD’s proprietary data assets and analyses as a tool to ensure comprehensive and accurate reviews of high-impact, high-cost therapies. By leveraging these capabilities, ICER will benefit from this increased capacity to scan, interpret, and anticipate key shifts in the landscape.
“IPD Analytics is an unbiased, independent organization that works to drive efficiency and transparency in the prescription drug market,” said Steven D. Pearson, MD, MSc, President of ICER. “We value their rigorous and thoughtful analysis of the drug pipeline, and we look forward to using this information as a key resource to support our internal horizon scanning efforts and to inform our process for selecting assessment topics.”
Howard Krass, CEO of IPD Analytics, also shared excitement for the collaboration. “We believe in ICER’s mission, and are pleased to work with them in furthering our shared goal of enhancing transparency regarding drug availability and pricing.”
The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.
ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.
About IPD Analytics
IPD Analytics is a provider of insight, transparency, and efficiency for stakeholders across the pharmaceutical landscape. The company identifies, projects, and quantifies the impact of competitive landscape shifts in the biopharmaceutical market. By combining proprietary data with uncommon expertise, IPD syndicates meaningful insights and curated information across four key capabilities: Life Cycle Insights, Payer and Provider Insights, Market and Financial Insights, and Coding and Reimbursement.
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September 30, 2019
Leslie Fish, RPh, PharmD Participates in the Advisory Board Company's Value Summit
Happy to have one of IPD’s Executive Clinical Pharmacists, Leslie Fish, R.Ph, Pharm.D., participate in The Advisory Board Company's Value Summit to share perspectives on how different parts of the industry define, measure, and drive medical value.
Leslie Fish, RPh, PharmD Speaks to Students at UMass
Even with her busy year-end work schedule, our VP of Clinical Pharmacy, Leslie Fish, PharmD, found time to speak on drug pricing to students in the "Health Policy and the Practice of Medicine" interstitial curriculum at University of Massachusetts Medical School.
April 29, 2020
IPD Analytics Experts Discuss Humira's Influence on Biosimilars
Center for Biosimilars | www.centerforbiosimilars.com
CfB: Hello, I'm Matthew Gavidia. Today on MJH Life Sciences News Network, The Center for Biosimilars is pleased to welcome Dr Leslie fish, vice president of Clinical Pharmacy for IPD analytics and Jeffrey Casper, vice president of Clinical Pharmacy for IPD analytics.
So, important litigation is now completed, and we now know the path to competitor biosimilars to adalimumab. Can you discuss the significance of this progress and what it means for the adalimumab market in 2023?
Casberg: Sure. Here at IPD, we have been watching for potential biosimilar Humira [adalimumab, AbbVie] for quite a few years now. We thought there could have been a biosimilar launch as early as 2019, or even 2020 [or] 2021. But as we watched the trials proceed between AbbVie and these competitors, AbbVie was winning these trial cases. The result of AbbVie winning is biosimilar manufacturers of Humira have signed what's called settlement agreements. So, they've sat down with AbbVie and signed a document stating that they won't launch their biosimilar product until x date. Currently, there's about 9 settlement agreements signed. Within those 9 settlement agreements with 9 manufacturers, 5 of them have approved products already. One of the reasons why we speculate that the biosimilar manufacturers sign these so-called settlement agreements is that if they had pushed and won in court early, they could have launched, but they probably would not have been able to launch with the full label. In other words, all the indications wouldn't have been there. So, we speculate at IPD that 1 of the motivations to sign the settlement agreement is AbbVie then gave them the full label to come out in 2023. So again, there are 9 manufacturers that have signed. 5 [have been] approved currently and there could be a number more on the way. see more