Friday, January 26, 2024

A $10Bn Target: Stelara Sales Break Barrier Ahead Of Biosimilar Launches

(1/26, David Wallace, Generics Bulletin) ...Stelara (ustekinumab) brought in $10.858bn for Johnson & Johnson in 2024, according to the latest figures reported by the originator, with this total up 11.7% over 2023's $9.723bn. In the US, sales grew by 9% to $6.966bn; while internationally, the brand achieved $3.892bn in sales, a 16.7% improvement over 2022...[C]hief financial officer Joe Wolk acknowledged that the firm "anticipated Stelara biosimilar entrants in Europe in the second half of this year," while US competition was lined up for early 2025. Both Amgen and Alvotech have secured date-certain entry for their biosimilars in the US through settlements with J&J. Amgen is able to launch from 1 January 2025, while Alvotech and marketing partner Teva can follow with a launch "no later than 21 February 2025"... Global Sub. Full

Zydus And Synthon Sign US Ibrance Generic Deal With Potential Exclusivity

(1/25, Urte Fultinaviciute, Generics Bulletin) ...Zydus Lifesciences has joined forces with Synthon by signing an exclusive licensing and supply agreement for palbociclib. While Synthon will be responsible for the manufacturing, supply, and US Food and Drug Administration registration, Zydus will take care of the drug's commercialization in the US market... Global Sub. Full

Senate Finance Unveils Framework For Bipartisan Bill To Stem Drug Shortages

(1/25, Maaisha Osman, InsideHealthPolicy) ...The Senate Finance Committee is crafting bipartisan legislation to tackle drug shortages that it says may include Medicare payment changes, reforms to stabilize the supply of generic sterile injectables (GSIs), incentives for hospitals and pharmacies to procure generic drugs based on quality, reliability and sustainable contracts, and reforms to the Medicaid Drug Rebate Program. A framework for the bipartisan legislation, unveiled Thursday (Jan. 25), includes revamping contracts between hospitals, group purchasing organizations and GSI manufacturers... Sub. Req’d

Crapo, Wyden Release Plan to Prevent and Mitigate Generic Drug Shortages

(1/25, Senator Mike Crapo) ...Washington, D.C.--U.S. Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and Chair Ron Wyden (D-Oregon) announced their commitment to working on bipartisan health care legislation to prevent and mitigate shortages of critical generic drugs used by patients and providers in the United States. In a white paper released today, Crapo and Wyden outline concerns raised by experts at a December 5, 2023 Finance Committee hearing, as well as areas of interest and ideas the Committee is exploring to address the factors contributing to shortages through modifications to the Medicare and Medicaid programs... Full

Key Senate Panel Considers Medicare Bonuses for Hospitals That Prevent Drug Shortages

(1/25, John Wilkerson, STAT Plus) ...The paper includes as many questions as proposals, but a theme has emerged. Many proposals call for paying hospitals more when they maintain buffer supplies and buy from drugmakers that invest in shortage mitigation measures... Sub. Req’d

Senate Finance Committee Plots Ways to Tweak Medicare to Reduce Sterile Injectable Shortages

(1/25, Zachary Brennan, Endpoints News) ...Specifically, a co-authored white paper, published Thursday, pledges to create a new payment benchmark for generic sterile injectables, including potential "lump-sum payments or other mechanisms" for those helping to prevent and mitigate shortages. But the committee is grappling with how certain design features of the new benchmark for generic injectables will look, including how it "would avoid exacerbating race to-the-bottom pricing" while promoting competition. Any moves will be welcome news for hospitals and others dealing with the generic shortages, which accounted for 63% of drugs in shortage between 2013 and 2017, according to an FDA analysis of sterile injectables from 2019... Full

Sanders Ratchets up Criticism of Drug Company CEOs Ahead of Possible Subpoena

(1/25, Nathaniel Weixel, The Hill) ...During a press conference Thursday, Sanders pointed to promises he said were extracted from the top executives at Moderna and Eli Lilly. For Moderna, the company pledged to make the COVID-19 vaccine available for free to uninsured and low-income people. Eli Lilly's CEO Dave Ricks told Sanders during a hearing last year that the company wouldn't raise prices on any insulin products currently on the market. Sanders is ratcheting up the pressure on drug company CEOs ahead of a potential vote on subpoenas next Wednesday... Full

‘I Think We Will Have The Votes': Sanders Gears up to Subpoena CEOs of J&J, Merck to Testify on Drug Prices

(1/25, Lia DeGroot, Endpoints News) ...In a statement to Endpoints News, Brian Smith, a partner at Covington & Burling who serves as outside counsel to J&J, said that the company has complied with the committee's requests. "There's no reason for a subpoena as Johnson & Johnson has cooperated with the Committee and offered to make one of its executives with expertise in the noticed topic available to testify at a hearing," Smith said. "I can't recall any instance in which this committee has issued a subpoena in the face of such cooperation." Merck also maintained that it's cooperated with the committee on its request, saying that it offered to make the company's head of US business available to provide testimony... Full

Merck CEO Refused to Testify in Senate Because He's Not an Expert in Drug Pricing, Bernie Sanders Says

(1/25, Rachel Cohrs, STAT Plus) ...Sanders, who has threatened to subpoena the CEOs of Merck and Johnson & Johnson over their refusal to testify at a hearing on why drug prices are higher in the United States than other countries, told reporters the reasons the companies gave ranged from "laughable" to "absurd."...Merck's CEO, Robert Davis, has a law degree from Northwestern University. The company declined to comment specifically on Sanders' remarks, but said that the company had offered to have the head of its U.S. business, who is responsible for U.S. pricing and commercialization strategy, testify... Sub. Req’d

The FTC Escalates Biden's Fight Against Drug Prices

(1/25, Elisabeth Rosenthal, KFF Health News) ...This past year, [the FTC] has issued more stringent guidelines to block and discourage hospital mergers, and it investigated practices by middlemen in the drug supply chain. Now drug manufacturers themselves are in the agency's crosshairs. In November, the FTC challenged the validity of more than 100 drug patents in the Food and Drug Administration's "Orange Book." It's a novel attack on drug prices... Full

Medicare Advantage Members Are More Likely to Use Biosimilars

(1/25, Carina Belles, Pink Sheet) ...Researchers from CMS, the FDA and policy research firm Acumen LLC studied claims and encounter data to calculate market share for 20 biosimilars across seven product categories. Biosimilar uptake was higher for MA members in every category but bevacizumab, the generic name for Genentech's targeted cancer therapy Avastin. Avastin currently has four biosimilars available, with a fifth approved last month... Sub. Req’d

Generic Drug Group Sues to Block Illinois Drug Pricing Law

(1/25, Brendan Pierson, Reuters) ...In a lawsuit filed Monday, in federal court in Chicago, the Association for Accessible Medicines said the law, which was passed last year and took effect this month, regulates sales outside of Illinois because it applies to any drugs that ultimately end up in the state. That runs afoul of the U.S. Constitution's Commerce Clause, which does not allow states to regulate commerce outside of their borders, it said... Full

AAM Files Against Illinois Generic Drug Price Gouging Bill

(1/25, Luke Zarzecki, InsideHealthPolicy) ...The generic drug lobby alleges the Illinois law is unconstitutional. "The Illinois law, an unconstitutional overreach signed into law in July 2023 and taking effect this month, grants Illinois sweeping powers to regulate the national pharmaceutical market, violating the United States Constitution and posing harm to vulnerable patient communities," AAM says in a statement on its suit... Sub. Req’d

Generic Group Sues Illinois Over a Price-Gouging Law With ‘Draconian Regulations'

(1/25, Ed Silverman, STAT Plus) ..."Generic drug manufacturers already face significant competitive and regulatory hurdles to bringing their life-saving and cost-reducing medicines to patients," AAM said. "The Illinois law's penalties will only add to those burdens, potentially forcing generics out of the market, harming Illinois patients and benefiting no one — except potentially brand-name pharmaceutical companies."... Sub. Req’d

FDA's Califf Is ‘Very Worried' About Judges Overruling Agency Decisions

(1/25, Brenda Sandburg, Pink Sheet) ...The US Food and Drug Administration is routinely sued by companies who object to its decisions, but Commissioner Robert Califf is concerned that judges are now more willing to overrule FDA's scientific judgements. Califf commented on the change in FDA's position before the courts during a recent Healthcare Unfiltered podcast focused on the agency's accelerated approval regulatory pathway... Sub. Req’d

FDA Final Guidances Aim to Streamline ANDA Reviews

(1/25, Ferdous Al-Faruque, Regulatory Focus) ...On 24 January, FDA published two guidances as part of its Drug Competition Action Plan (DCAP). According to the agency, the objective is to streamline the generic drug review process without compromising regulatory rigor to help bring new generics to market and increase competition..."An efficient generic drug review process helps to expand access to safe, high-quality, effective generic medicines," said FDA in a statement announcing the guidances... Full

Trade Secrets In Court: Are Dissolution Specifications That FDA Gave Vanda Proprietary?

(1/25, Brenda Sandburg, Pink Sheet) ...The US Court of Federal Claims expressed concern that Vanda Pharmaceuticals, Inc.'s trade secrets claims against the US Food and Drug Administration could negatively impact the agency's ability to assist drug manufacturers with their applications, though it allowed some of them to proceed... Sub. Req’d

How Drug Companies Use Authorized Generics To Keep Drug Prices High

(1/25, Ike Brannon, Forbes) ...If GSK reduces the price of the authorized generic to recapture commercial market sales it will lose revenue in Medicaid, and if it does not cut its price it will miss out on sales in the commercial market. At the same time, the Medicaid policy change at the root of this problem is unlikely to be unwound. What we can expect is for lawmakers to point fingers everywhere except at themselves... Full

340B And Innovation: Study Says Hospitals Keeping Rx Payments That Could Otherwise Fuel Drug R&D

(1/25, Cathy Kelly, Pink Sheet) ...Published in the New England Journal of Medicine on 25 January, the study examines the price markups and reimbursement collected by hospitals participating in the 340B program compared to non-participating hospital and independent physician practices. It focuses on commercial reimbursement using national Blue Cross Blue Shield claims data from 2020-2021 for physician administered drugs... Sub. Req’d

Congresswomen Elissa Slotkin and City Leaders Have Teamed Up to Solve The Drug Shortage Issue

(1/25, Travis Hicks, Fox 47 News) ...The Eaton Rapids medical center, like so many healthcare facilities in our neighborhoods, is having trouble finding certain prescriptions. "I think what most people don't understand is that most of our drug supply comes from overseas" Congresswomen Elissa Slotkin said. This is why democratic congresswoman Elissa Slotkin is backing legislation to help the shortage... Full

EU Plan for Medicine Stockpile Could Worsen UK's Record Shortages

(1/25, Denis Campbell, The Guardian) ...The EU is to stockpile key medicines that will worsen the record drug shortages in the UK, with experts warning that the country could be left "behind in the queue"...Mark Samuels, the chief executive of the British Generic Manufacturers Association, which represents generic drugmakers, said the government's recent decision to increase the amount it claws back from manufacturers of generic drugs, if their sales exceed an agreed level, risked turning some products into loss-makers that would become uneconomic to bring into the UK... Full

WHO Pandemic Accord Delays And Potential To Fail Concern IGBA

(1/26, Dean Rudge, Generics Bulletin) ...The International Generic and Biosimilar Medicines Association has expressed "deep concern" about delays in the negotiations for the World Health Organization Pandemic Preparedness Treaty, and, more broadly, "the potential for WHO member states to fail to reach an agreement," as the off-patent industry association weighed in on the proposed text ahead of its proffered final submission in May... Global Sub. Full

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