Biosimilars

New FDA Approvals: The FDA Granted an Additional Indication to Lynparza

April 13: The FDA approved Amneal Pharmaceuticals, Inc.’s Alymsys (bevacizumab-maly) for the treatment of multiple conditions: (1) first- or second-line treatment of metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy; (2) second-line treatment of metastatic colorectal cancer in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin chemotherapy in people who have progressed on a first-line bevacizumab product; (3) first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel; (4) recurrent glioblastoma in adults; (5) metastatic renal cell carcinoma in combination with interferon alfa; (6) persistent, recurrent or metastatic cervical cancer in combination with paclitaxel and cisplatin or paclitaxel and topotecan; and (7) epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan for platinum-resistant recurrent disease in people receiving no more than two prior chemotherapy regimens. The vascular endothelial growth factor inhibitor is the third biosimilar of Roche Group member Genentech USA, Inc.’s Avastin (bevacizumab) that the agency has approved. Dosing of the intravenous infusion is based on indication.

Major PBMs Look Ahead to 2023 for Biosimilars Boom

With a raft of biosimilars coming to market starting in 2023, major PBMs are touting the pharmacy infrastructure and services that they say will position them to help customers take advantage of cost-saving opportunities in the coming years.

Speaking during recent conference calls to discuss first-quarter 2022 financial results, they also reported healthy client retention levels as PBMs move through the large-employer selling season.

“Our team is quite excited about and well positioned for the accelerating biosimilar trend that we see in front of us for the coming years,” Cigna CEO David Cordani said during a May 6 conference call to discuss first-quarter 2022 financial results, per a transcript from The Motley Fool.

Most Payers Will Review Humira Biosimilars as They Come

Starting next year, biosimilars are expected to generate significant pharmacy cost savings for patients and payers, led by multiple biosimilars of AbbVie Inc.’s blockbuster immunosuppressive drug Humira (adalimumab). With as many as eight Humira competitors expected to launch in 2023, most payers report they will evaluate the biosimilars as they come to market over the course of the year, rather than waiting until all are available before making coverage decisions. And half of payers may adjust Humira contracting in 2022, prior to the biosimilars’ launches.

That’s according to findings from Zitter Insights, which like AIS Health is a division of MMIT. Steve Callahan, a senior manager of market research at MMIT, described Zitter’s market research findings on the Humira biosimilars during an April 5 webinar.

Biosimilars Stand to Cut Costs for Medicare Part D and Beneficiaries, If Uptake Improves

New biologic drugs cost Medicare Part D and its beneficiaries almost $12 billion in 2019, but increased biosimilar uptake could cut spending significantly in coming years, according to a March report from HHS’s Office of the Inspector General (OIG). Specifically, the OIG report pointed to upcoming launches of Humira (in 2023) and Enbrel (in 2029) biosimilars as potential catalysts for change. The two biologics alone accounted for nearly half of 2019’s Part D spending. Studying 2019 Part D plan formularies, OIG found that biosimilar uptake for four select drug classes was limited due to lack of coverage, and formularies that did cover biosimilars did not encourage their use over the original reference products despite their lower cost. OIG advised CMS to encourage payers to place biosimilars on formulary, which the agency agreed with. As of the second quarter of 2022, most Medicare beneficiaries still have better access to the biologics OIG studied over their biosimilars, with the exception of Teva Pharmaceuticals’ Granix, a biosimilar to Amgen’s Neupogen, and Pfizer’s Retacrit, a biosimilar to Amgen’s Epogen and Johnson & Johnson’s Procrit. Granix holds covered or better status for 51% of Medicare beneficiaries, according to data from MMIT Analytics (MMIT is the parent company of AIS Health). Retacrit, meanwhile, holds 66% covered or better status.

News Briefs: Teva Launches First Generic of Revlimid in U.S.

Teva Pharmaceuticals Ltd. launched the first generic version of Bristol Myers Squibb unit Celgene Corp.’s Revlimid (lenalidomide) in 5 mg, 10 mg, 15 mg and 25 mg strengths in the United States on March 7. The FDA approved the drug from Teva U.S. affiliate Arrow International Ltd. and Natco Pharma Ltd. on May 21, 2021. The companies have tentative approval for the 2.5 mg and 20 mg strengths due to an exclusivity issue: The FDA has approved Dr. Reddy’s Laboratories Ltd.’s lenalidomide for those dosages. The product is approved for three indications: (1) multiple myeloma in combination with dexamethasone, (2) transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenic abnormalities and (3) mantle cell lymphoma that has relapsed or progressed after at least two treatments, including bortezomib. The launch is limited, and through an agreement with Celgene, the companies are allowed to sell “mid-single-digit percentages” of Revlimid’s total volume this month, a figure that gradually will increase to one-third of the volume. Beginning Jan. 31, 2026, Teva can sell the drug without volume limitation. Multiple companies are expected to launch Revlimid generics in the U.S. this year.

Nonprofit Will Sell $30 Insulin Direct to Patients Starting in 2024

CivicaRx, the nonprofit drug manufacturer owned by a consortium of health systems and health plans, aims to release a line of three insulins — glargine (Lantus), lispro (Humalog) and aspart (Novolog) — as soon as 2024. Those insulins will be available in vials or prefilled pens and will be priced at “no more than $30 per vial and no more than $55 for a box of five pen cartridges” for all consumers, regardless of whether they have insurance; the products will soon be submitted for review for interchangeable biosimilar approval by the FDA.

The CivicaRx initiative could do something that existing proposals to cap the price of insulin would not: It may actually lower the list price of insulin products. Ge Bai, Ph.D., tells AIS Health, a division of MMIT, that she expects the insulins will set the standard price in their category when they become available. (Bai, a professor at Johns Hopkins University’s schools of business and public health, has authored several publications with Dan Liljenquist, an executive at the Intermountain Healthcare hospital system and the chair of CivicaRx’s board.)

Big 3 Implement Conflicting Formulary Exclusions on Biosimilars

The Big Three PBMs — Cigna Corp.’s Express Scripts, UnitedHealth Group’s OptumRx, and CVS Health Corp.’s Caremark — once again added new drugs to their formulary exclusion lists for the 2022 plan year, but the rate of new exclusions slowed. Industry insiders tell AIS Health, a division of MMIT, that the slowing amount of exclusions indicates the PBMs find high value in opaque, complex contracting agreements with providers, even though certain preferences in areas like insulins, specialty drugs and biosimilars defy the logic of list prices.

According to an analysis of plan documents by Adam Fein, Ph.D., CEO of the Drug Channels Institute, Caremark now excludes 433 products from its formularies, Express Scripts excludes 485 and OptumRx excludes 492. Each amount sets a record number of exclusions for each company.

2022 Outlook: Notable FDA Approvals, Payer Strategies Are Specialty Trends

The specialty pharmacy industry will continue its growth in 2022, experts tell AIS Health, a division of MMIT. Multiple agents for rare diseases are poised for FDA approval, and the market may see additional cell and gene therapies. In addition, payers will carry on their efforts to keep prices for specialty medications affordable, among other trends.

AIS Health: What are some specialty pharmacy issues to keep an eye on in 2022, and why?

Biosimilar Approvals Are Expected to Undergo Upward Trend in 2022

The FDA approved only four biosimilars in 2021, down from its high of the 10 it approved in 2019, but slightly more than the three such therapies approved in 2020. The agency also granted interchangeability to the first two biosimilars. This year may up the excitement level, industry experts tell AIS, a division of MMIT, with numerous products expected to be approved, while other noteworthy therapies will lose patent protection and potentially face biosimilar competition.

Dea Belazi, Pharm.D., M.P.H., president and CEO of AscellaHealth: The United States has been slow to approve and adopt biosimilars. Since the initial biosimilar approval in 2015, the FDA has approved 33 biosimilars, but only 18 are currently available on the U.S. market with a projected market value of $13 billion in 2021. Even with this slow uptake in the United States, there is increased utilization and a growing pipeline of products that will drive use and savings. In 2021, many blockbuster drugs were approved in the biosimilar space, along with the two interchangeable biosimilar products, [Boehringer Ingelheim Pharmaceuticals, Inc.’s] Cyltezo and [Viatris Inc. and Biocon Ltd. subsidiary Biocon Biologics Ltd.’s] Semglee.

Big 3 Implement Conflicting Formulary Exclusions on Biosimilars

The Big Three PBMs — Cigna Corp.’s Express Scripts, UnitedHealth Group’s OptumRx, and CVS Health Corp.’s Caremark — once again added new drugs to their formulary exclusion lists for the 2022 plan year, but the rate of new exclusions slowed. Industry insiders tell AIS Health, a division of MMIT, that the slowing amount of exclusions indicates the PBMs find high value in opaque, complex contracting agreements with providers, even though certain preferences in areas like insulins, specialty drugs and biosimilars defy the logic of list prices.

According to an analysis of plan documents by Adam Fein, Ph.D., CEO of the Drug Channels Institute, Caremark now excludes 433 products from its formularies, Express Scripts excludes 485 and OptumRx excludes 492. Each amount sets a record number of exclusions for each company.