Thursday, March 14, 2024

Payors Take Lead From FTC In Suing BI Over Its Orange Book Patent Listings For Inhalers

(3/13, Brenda Sandburg, Pink Sheet) ...Class action complaint alleges Boehringer Ingelheim engaged in a ‘Respimat Orange Book scheme' to thwart generic competition for Combivent Respimat and Spiriva Respimat that cost payors millions, if not billions, in overcharges...The FTC did not specify why the listings were improper. Rahul Rao, a deputy director of the FTC's Bureau of Competition, told the Pink Sheet that only patents that claim the active ingredient should be listed in the Orange Book and drug-device patents that do not claim the active ingredient should not be listed. BI, AstraZeneca PLC and Teva Pharmaceutical Industries Ltd. rejected the FTC's claims and said they would not delist their patents... Sub. Req'd

Biocon Biologics: US Biosimilars Are A Marathon, Not A Sprint

(3/13, David Wallace, Generics Bulletin) ...Biocon Biologics has a long-term commitment to biosimilars. That is the message that came across clearly from the firm's chief commercial officer for advanced markets, Matt Erick, as he spoke to Generics Bulletin about how competition in the US biosimilar was a "marathon" that is "not going to be won in the short term."... Global Sub. Full

Samsung Bioepis' Stelara Biosimilar Shows Long-Term Similarity In Plaque Psoriasis

(3/13, Urte Fultinaviciute, Generics Bulletin) ...With less than a year left until the first biosimilars to Johnson & Johnson's Stelara (ustekinumab) start entering the US market, Samsung Bioepis presented new long-term clinical trial data for its candidate SB17 in plaque psoriasis. The Korean firm announced the final 52-week results from the Phase III clinical trial comparing the long-term efficacy, safety, and immunogenicity of SB17 to reference ustekinumab at the 2024 American Academy of Dermatology Annual Meeting... Global Sub. Full

Sandoz Reports Fourth Quarter 2023 Sales and Full-Year 2023 Results

(3/13, Sandoz) ...Net sales for the fourth quarter were USD 2.5 billion, up 10% in constant currencies, compared to the fourth quarter of 2022. Volume contributed 12 percentage points of growth, partially offset by price erosion of 2 percentage points. All regions showed growth this quarter with solid contribution from generics and strong performance in biosimilars, across new and existing products. Net sales for the full year were USD 9.6 billion, up 7% in constant currencies compared to 2022... Full

Coherus Again Axes Staff, With 30% of Roles On Chopping Block Amid ‘Sharpened Focus' On Cancer Drugs

(3/13, Angus Liu, Fierce Pharma) ...Coherus unveiled the latest job cuts Wednesday alongside its full-year 2023 financial results...The layoffs come as a result of a "sharpened focus" in oncology and a subsequent restructuring, Coherus said. The company in January announced that it will sell its ophthalmology franchise surrounding its Lucentis biosimilar to Sandoz for $170 million in cash. The latest job cuts include 35 employees as part of the ophthalmology divestiture. The Lucentis copycat, branded as Cimerli, generated $52 million in fourth-quarter sales for Coherus, bringing its full-year total to $125 million... Full

Eli Lilly CEO David Ricks Talks China, AI, and Pharma's Next 'Golden Era' After Obesity

(3/13, Andrew Dunn, Endpoints News) ...Eli Lilly CEO David Ricks shared his view from the pharma industry's peak in an hourlong conversation Tuesday with the Economic Club of New York. Ricks weighed in on everything from Alzheimer's and AI to China tensions and the future of direct-to-consumer drug sales. Of course, there was also no avoiding the key driver of Lilly's industry-leading pole position: its megablockbuster obesity drugs. Here's how the CEO of the drugmaker now valued at $716 billion — more than the bellwethers Johnson & Johnson and Merck combined — sees the state of the industry... Full

India's Biocon to Sell Branded Formulations Business to Eris Lifesciences for $150 Mln

(3/14, Varun Vyas, Reuters) ...Biopharmaceutical company Biocon's unit Biocon Biologics will sell its Indian branded formulations to Eris Lifesciences in a deal worth 12.42 billion rupees ($150 million), the companies said in separate exchange filings on Thursday...The deal includes the acquisition of two insulin brands, Basalog and Insugen, which Eris said will help its diabetes treatment franchise reach 10 billion rupees in revenue, without specifying a timeline... Full

Biocon Biologics Signs 10-Year Supply Deal With Eris Lifesciences for Rs 1242 Crore

(3/14, Neethi Rojan, Money Control) ...Biocon Biologics has signed a 10-year supply agreement with Eris, as a part of this deal. The transaction is expected to come into effect on April 1, 2024...This collaboration is in line with Biocon Biologics' strategy to unlock value from its legacy business of branded formulations built over the past two decades and extends its existing partnership with Eris for Biocon's Nephrology and Dermatology business announced in Dec 2023, according to the company... Full

Aurobindo Unit Begins Shipping Drugs from India Plant After FDA Inspection Triggered Production Halt

(3/13, Joseph Keenan, Fierce Pharma) ...Previously, the company said it had restarted manufacturing on its "terminally sterilized" production lines at the plant. Now, the company has "started distribution of aseptic products" made there, Aurobindo said in a Tuesday filing. "We also expect to start commercial production from the aseptic lines of the said facility in a phased manner beginning next week and to restart all the lines by April 15, 2024," Aurobindo added... Full

UnitedHealth Unit Change Healthcare's Pharmacy Network Back Online

(3/13, Leroy Leo and Shivani Tanna, Reuters) ...UnitedHealth Group said on Wednesday its unit Change Healthcare's pharmacy network was back online, weeks after a cyberattack had a knock-on effect across the country's healthcare system that depends heavily on insurance...As of March 13, all major pharmacy and payment systems are up and more than 99% of pre-incident claim volume is flowing, UnitedHealth said. The company, however, added that its teams are working on some pharmacies that are still offline... Full

Hackers Roil Entire Industries With Attacks on IT Supply Chain

(3/14, Jordan Robertson, Bloomberg Law) ...Those attacks, against EquiLend and UnitedHealth Group Inc.'s Change Healthcare division, wreaked havoc on Wall Street and the American health-care system...The latest attacks reveal that many industries don't understand weaknesses in their own networks that can cripple them - and the degree to which they've become dependent on vulnerable third parties, according to Federico Charosky, founder and chief executive officer of Edinburgh, Scotland-based cybersecurity firm Quorum Cyber... Sub. Req'd

Fragmented Payer System, Vulnerable Supply Chain Among Threats to Accessing Essential Medicines

(3/13, Christina Mattina, AJMC) ...During a session of the 2024 V-BID Summit, panelists Stacie Dusetzina, PhD, and Inma Hernandez, PharmD, PhD, discussed how access to essential medications is curtailed not just by the longstanding complexities of insurance design but also by emerging threats such as supply chain weaknesses and cyberattacks... Full

Biden's Co-Pay Cap Is Silver Lining For Pharma In Drug Pricing Campaign

(3/13, Michael McCaughan, Pink Sheet) ...There is certainly much more for industry to fear than love in Biden's campaign-year drug pricing agenda. But if the call for a national limit on copays carries forward past November, it could be a significant win for brand name companies... Sub. Req'd

Could Symbicort and Farxiga Users Be Getting a Break On Prices?

(3/13, Gary Guthrie, Consumer Affairs) ...In a lawsuit that could knock drugs like Symbicort and Farxiga off their high priced perch, a federal court in Delaware has sent AstraZeneca's lawyers home with a rejection slip after the drugmaker challenged the Medicare drug price negotiation provisions of the Inflation Reduction Act...New legislation allows Medicare to haggle over prices of expensive medications starting in 2026. Medicare's game plan has been to focus on drugs with no generic competition and pick the most expensive ones first. AstraZeneca has its share of those types of medications. For example, GoodRx says that the AZ-branded version of Farxiga lists at $681.20 per 30-day, 10mg supply. Symbicort – AZ's inhaler used for asthma and COPD rounds – lists for $515... Full

Casey Introduces Bill to Eliminate Copays for Hundreds of Thousands of Pennsylvania Seniors

(3/13, U.S. Senator For Pennsylvania Bob Casey) ...The law would remove cost-sharing for generic medications for all Americans who are enrolled in the Medicare Part D Low Income Subsidy Program (also known as Extra Help) and make less than $15,060 per year. Currently, this population of Extra Help beneficiaries pay up to $1.55 for each generic drug they are prescribed—Casey's bill would cut that number to zero. In 2021, over 350,000 Pennsylvanians could have benefitted from this bill... Full

Drug Shortages: A Guide to Policy Solutions

(3/13, Marta Wosinska, Brookings) ...Our drug supply chains are not as reliable as we expect them to be, resulting in disruptions in medical care and causing patient harm. But little progress will take place unless there is a systemic change in the economic dynamics and the misaligned incentives that exist in the marketplace. Because economic dynamics are at play, there is an important role for the U.S. government to drive change... Full

Biotech Trade Group Pledges Support for BIOSECURE Act, Plans to Boot Member WuXi AppTec

(3/13, Eric Sagonowsky, Fierce Pharma) ...Wednesday, the Biotechnology Industry Organization (BIO) said it's taking "important steps" to support U.S. national security. Those steps include supporting the BIOSECURE Act, which looks to prevent "adversary biotech companies" from obtaining federal funding. BIO also plans to take steps to remove WuXi AppTec from its membership roster, the trade group said... Full

Biosimilars Council Applauds the President's Budget Proposal to Eliminate the Arbitrary Distinction Between Interchangeable Biologics and Biosimilars

(3/13, Biosimilars Council) ..."The Biosimilars Council applauds the administration for including biosimilars in their proposed budget," said Craig Burton, Executive Director, Biosimilars Council and AAM Senior Vice President, Policy and Strategic Alliances. "The distinction between interchangeable biologics and biosimilars is not supported by science and continues to permit brand misinformation. The proposal would reduce confusion and increase patient access to lower cost biosimilars. The Biosimilars Council looks forward to working with the administration and Congress to expand patient access to lower cost biosimilars."... Full

FDA Pushes Legislative Proposals To Boost Generic Competition

(3/13, Jessica Karins, InsideHealthPolicy) ...The agency's document laying out its legislative proposals includes a section on facilitating competition, which also requests Congress require full ingredient disclosure for drugs, close patent litigation loopholes, ease requirements for generic drug-device combination products and enhance the availability of generic animal drugs. One major policy change sought by the agency would eliminate the statutory distinction between biosimilar and interchangeable drugs. FDA Commissioner Robert Califf spoke to that change, which the president's budget proposal listed as a budget-neutral way to increase drug competition, at a press conference Monday (March 11)... Sub. Req'd

FDA Calls For Limited Three-Year New Drug Exclusivity To Support Generics

(3/13, Urte Fultinaviciute, Generics Bulletin) ...If the proposed change is accepted, biosimilars would "no longer include a separate statutory standard for a determination of interchangeability and to deem all approved biosimilars to be interchangeable with their respective reference products." It is still unclear if these changes will happen soon, given that the proposed ideas touch on policies that the two political parties in the US disagree on... Global Sub. Full

Recall Authority, Notification Requirements In FDA Legislative Asks

(3/13, Luke Zarzecki, InsideHealthPolicy) ...FDA's legislative proposals for fiscal 2025 continue the agency's efforts to seek more authorities it says would help address medical product shortages and build supply chain resiliency, asking Congress to give FDA the ability to require more notifications from manufacturers, implement mandatory recalls and more... Sub. Req'd

US FDA Seeks More Power To Confront ‘Shadow' Factory Challenges

(3/13, Bowman Cox, Pink Sheet) ...Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy's plant and seeks to find manufacturer of contaminated eye drops that disappeared. In a series of recent actions, the US Food and Drug Administration has shown that there are still cases of hidden, substandard facilities manufacturing adulterated drug products for the US market and it will go to great lengths to prosecute such operations. It also is pressing Congress for new authorities that will give it a greater ability to identify such facilities and protect patients from them... Sub. Req'd

US FDA Wants Advisory Committee Duty To Be ‘Enjoyable'

(3/13, Derrick Gingery, Pink Sheet) ...Advisory committee reform efforts include streamlining the selection and onboarding processes, in part to understand that members often have other professional priorities, Principal Deputy Commissioner Namandjé Bumpus said. The US Food and Drug Administration wants to be more understanding of advisory committee members' professional lives as part of its ongoing effort to reform the system... Sub. Req'd

Surely You Must be Kidding, PTO?!? "No, and Don't Call Me Shirley!" – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 3 . . . and PART 3½)

(3/14, Kurt R. Karst, FDA Law Blog) ...Part 1 focused on both the PTO's historical and current (180-degree and unsupported change in position) on multiple PTEs. Part 2 ("Part Deux") investigated the PTO's position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act's Accelerated Approval provisions (and otherwise). Today, we move on to Part 3 concerning a group of PTO decisions that left us floored... Full

Appeals Court Affirms Arkansas Law Against Drugmakers' 340B Contract Pharmacy Restrictions

(3/13, Dave Muoio, Fierce Healthcare) ...The ruling was handed down Tuesday by the U.S. Court of Appeals for the Eight Circuit's three-judge panel. The judges disagreed with a pharmaceutical industry group's argument that Arkansas' 340B Drug Pricing Nondiscrimination Act passed in 2021 is preempted by existing federal law outlining the program, which requires drug manufacturers to sell drugs at a discount to safety-net providers... Full

CT Lawmakers Aim to Lower Prescription Drug Costs, But Some Say Bill May Make it Cost More

(3/14, Cris Villalonga-Vivoni, CT Insider) ...Questions and opposition have emerged against a state bill that would reduce the cost of certain prescription drugs. While supporters said the bill is needed, pointing to dire examples of people forgoing meals, taking fewer doses or buying on the black market so they could afford insulin, opponents said it could create more costs and might contradict existing laws. Others applauded the intention of the bill but said it didn't go far enough... Full

Oregon Prescription Drug Affordability Board Seeks Public Input About Drug Costs

(3/13, Ben Botkin, Oregon Capital Chronicle) ...The Oregon Prescription Drug Affordability Board will have community forums across the state in April and May to seek the public's input about soaring costs of prescription drugs. The board will use public comments on the costs of specific prescription drugs as a guide when working on the state's first plan for establishing price limits on prescription drug costs in Oregon... Full

EU Regulators and Industry Clash On Pharmaceutical Reform Package

(3/13, Joanne S. Eglovitch, Regulatory Focus) ...European Union officials said a proposal to reform the EU pharmaceutical legislation will go a long way towards providing equal access to new medicines, yet the proposal faced pushback from representatives of pharmaceutical companies who argued that shortening the marketing exclusivity periods for new drugs will hurt innovation and stymie clinical research in the region... Full

European Commission Finalizes Plan to Streamline Variation Process

(3/13, Nick Paul Taylor, Regulatory Focus) ...European Union lawmakers last made major changes to the Variations Regulation framework in 2012. As the Commission explained in a staff working document, the number of overall variations has increased since then, "Draining the resources of regulatory authorities and industry alike." The rise in workload has coincided with advances that show "there is room for improvement in terms of efficiency, flexibility and continuous adaptation to change," the Commission wrote... Full

EU's New Variations Rules Will Cut Regulatory Burden, But Some Are Less Happy Than Others

(3/13, Ian Schofield, Pink Sheet) ...Among the key features of the new framework are "super-grouping" of variations, a risk-based approach to classifying changes to biological products, and a more streamlined approach to updating pandemic vaccines. New EU rules that will allow variations to marketing authorizations to be processed more quickly are due to take effect at the beginning of 2025 after the European Commission adopted a "delegated regulation" amending the current variations regulation...The move has been generally welcomed by the pharmaceutical industry, although the German industry body, the BPI, group says it is "disappointed" its concerns have not been addressed... Sub. Req'd

European Health Data Space Talks Falter Over Opt-Out Issue

(3/13, Francesca Bruce, Pink Sheet) ...The pharmaceutical industry could potentially benefit from access to large volumes of patient data collected across the EU for use in certain R&D activities. According to the European Federation of Pharmaceutical Associations and Industries, the EHDS could "shape the future of health data and Europe's digital ecosystem, bringing enormous bene?ts to European patients, healthcare professionals and health systems." It warned that electoral timelines must not derail progress on the regulation... Sub. Req'd

EU Parliament to Extend New Medicine Data Protection to 7.5 Years, Document Says

(3/14, Julia Payne, Reuters) ...EU lawmakers have gone part of the way to meeting pharmaceutical industry concerns about the exclusivity period for new medicines after reaching a compromise on the biggest overhaul of EU pharmaceutical rules in 20 years, a parliament proposal showed...In the draft compromise, seen by Reuters, committee members have agreed to raise baseline data protection to 7.5 years with one extra year of incentives if the medication meets "unmet medical needs", and if clinical trials are held in the EU... Full

European Parliament Adopts Landmark AI Act

(3/13, Eliza Slawther, Pink Sheet) ...The European Commission's AI Act has been formally approved by the European Parliament, marking a historic day for AI governance globally. The new regulation has been touted as the world's first comprehensive legislation for AI systems, with many implications for the health care, medtech and pharmaceutical sectors...The new rules could affect pharmaceutical companies that use AI in any part of the drug development process, and specific guidance around AI use during the medicine lifecycle is set to be published by the European Medicines Agency this year... Sub. Req'd

Filgrastim Biosimilars in Europe: 15 Years of Real-World Evidence for Zarxio

(3/13, Skylar Jeremias, The Center For Biosimilars) ...A review, published in Critical Reviews in Oncology/Hematology, on the last 15 years of experience with the first filgrastim biosimilar (Zarxio) explored preclinical, clinical, and real-world evidence—as well as cost-effectiveness data—to demonstrate comparable safety and efficacy measures between the biosimilar and reference agent (Neupogen)... Full

Canadian Industry Remains Apprehensive About Pharmacare Reform

(3/14, Adam Zamecnik, Generics Bulletin) ...Despite welcoming the Canadian government's efforts in pushing through universal pharmacare, the Canadian Generic Pharmaceutical Association and Biosimilars Canada remain apprehensive about the legislation's potential impact on the supply of generic and biosimilar medicines on the market. Specifically, the president of the two organizations, Jim Keon, stated that biosimilars and generics producers will need to find out more about the government's planned implementation of the legislation while also discussing the matter with stakeholders in order to ensure a smooth transition that will maximize the use of generics and biosimilars... Global Sub. Full

Zydus Launches Anti-Cancer Generic Drug Olaparib in India

(3/13, Viswanath Pilla, The Economic Times) ...The drug will target specific genetic mutations prevalent in certain types of cancers, paving the way for a more tailored and effective treatment approach, the company said in a stock exchange filing. The drug will target specific genetic mutations prevalent in certain types of cancers, paving the way for a more tailored and effective treatment approach. Zydus Lifesciences on Wednesday said it has launched olaparib, a PARP inhibitor, under the brand name IBYRA in India, making advanced cancer treatment accessible to all... Full

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