Monday, September 16, 2024

Generics Bulletin Explains: US Generics Players Enjoy Calmer Waters

(9/16, David Wallace, Generics Bulletin) ...Meanwhile, another global off-patent industry giant was even more enthusiastic about the US generics market as it reported its latest sales and earnings results for the second quarter of 2024. Teva CEO Richard Francis heralded "significant growth" for the firm's US generics business, partly driven by its generic lenalidomide rival to top-selling multiple myeloma treatment Revlimid – a product that has provided an opportunity for multiple generics players – as well as complex generics launches such as the firm's recent authorized generic liraglutide version of Victoza. But essentially, Francis said, even outside of these specific product opportunities, the firm was enjoying "just an underlying good performance in our generics business"... Global Sub. Full

Sandoz Needs Strong End to Year to Hit Margin Target -- Market Talk

(9/16, Dow Jones) ...A full-year core Ebitda margin target of around 20% sets a high bar for the Swiss maker of generic drugs and could weigh on its shares for the remainder of 2024, following a 50% rise since the company's spinoff from Novartis, the analysts say. Next year, the company plans to launch several new products in the U.S. and it has further opportunities later this decade as blockbuster cancer drug Keytruda and weight-loss drugs start to lose patent protection in some markets, RBC says... Sub. Req’d

STADA Credits Biosimilar Expansion for Profitable First Half of 2024

(9/15, Skylar Jeremias, The Center for Biosimilars) ...STADA Arzneimittel gave kudos to biosimilar successes for its increased revenues for the first half of 2024, rising 9% from the same period the year prior, according to the company's earnings report..."STADA's ongoing growth journey bears testimony to the strength and resilience of our 3-pillar strategy – Consumer Healthcare, Specialty and Generics. Our first-half performance ahead of the industry is a direct result of the exceptional engagement, entrepreneurial vision, and growth culture among our around 11,500 colleagues around the world," stated Peter Goldschmidt, CEO of STADA... Full

Sandoz Wins $137 Million From UTC in Generic-Remodulin Clash

(9/13, Christopher Yasiejko, Bloomberg Law) ...Sandoz Inc. won $137.2 million in lost profits for United Therapeutics Corp.'s improper restriction of access to the injection cartridges needed for generic versions of the lung-pressure drug Remodulin, according to a New Jersey federal judge's unsealed ruling... Sub. Req’d

Real-World Study Shows Comparable Outcomes Between CT-P13, Remicade in RA

(9/14, Deana Ferreri, The Center for Biosimilars) ...They observed disease activity "remained stable" in patients who switched from the reference product or another infliximab biosimilar and improved in patients switching from a non-infliximab biologic or tsDMARD and in biologic/tsDMARD-naive patients. The study used data from CorEvitas RA Registry, a large, observational clinical registry including data collected from patients and their rheumatologists at routine visits... Full

Expanding Biosimilar Adoption: Insights and Strategies with Dr Sophia Humphreys

(9/16, Skylar Jeremias, AJMC) ...Sophia Humphreys, PharmD, MHA, BCBBS, director of system formulary management at Sutter Health, discusses the challenges of expanding biosimilars into new therapeutic areas and highlights the role of education, competitive pricing, and integrated delivery networks (IDNs) in improving adoption and market growth... Full

GoodRx: Evolving & Expanding Integrated Platform Partnerships to Drive Access, Affordability & Outcomes

(9/13, Rick Fry, Drug Channels) ...In July, GoodRx and Boehringer Ingelheim announced a patient affordability initiative to provide citrate-free Adalimumab-adbm, Boehringer's biosimilar to Humira (adalimumab), at a low cash price—the first biosimilar with this offer on GoodRx. In August, CMS announced prices of the first ten medications impacted by the Inflation Reduction Act that enables Medicare to "negotiate directly with drug companies to improve access to some of the costliest single-source brand-name Medicare Part B and Part D drugs."... Full

Generic Drug Group, ERIC, Small PBMs Lobby For Lame-Duck Bills

(9/13, InsideHealthPolicy) ...Separately, the generic drug lobby is calling for passage of bills to increase use of biosimilars and generics in Medicare through a demonstration and new formulary policies, create a safe-harbor for skinny labeling, and mitigate the unintended consequences of Medicare drug price negotiation, and it also asks lawmakers to scrap efforts to ban pay-for-delay pacts... Sub. Req’d

Statement Regarding Senate Judiciary Committee Markup of the PREVAIL Act and the PERA Act

(9/13, AAM) ...The Association for Accessible Medicines and its Biosimilars Council oppose passage of the PREVAIL Act and the PERA Act. PREVAIL will make it more difficult for generic and biosimilar manufacturers to challenge expensive brand-name drug patent thickets and bring lower-cost medicines to patients, and PERA will enable brand-name drug manufacturers to build even larger thickets and charge higher prices. We call on policymakers to proactively address patent thickets through passage of bipartisan, bicameral legislation such as S. 150, the Affordable Prescriptions for Patients Act, which will help streamline patent litigation and expedite patient access to lower-cost medicine... Full

House GOP Presses DEA on Adderall Shortage

(9/13, Gabrielle M. Etzel, Washington Examiner) ...On Friday, House Oversight Committee Chairman James Comer (R-KY) and Healthcare and Financial Services Subcommittee Chairwoman Lisa McClain (R-MI) sent a letter obtained by the Washington Examiner to DEA Administrator Anne Milgram requesting information regarding the agency's lack of action to increase the manufacturing limit on amphetamines necessary to treat ADHD, including Adderall, Vyvanse, Concerta, and Ritalin... Full

‘People Are Desperate': Illinois Harm Reduction Organizations Await Settlement Funding in Effort to Reduce Opioid Overdoses

(9/15, Olivia Olander, Chicago Tribune) ...While advocates credit the state for making harm reduction a priority in its ideals for addressing the crisis, smaller organizations without much administrative infrastructure say they're worried about being able to win grants and feel they are at risk of losing out to larger rehabilitation and recovery-based groups. And a wide range of organizations have raised concerns about the speed at which the massive settlements are being distributed... Full

HHS Awards $14 Million To Boost Domestic Production of Active Pharmaceutical Ingredients

(9/13, Maaisha Osman, InsideHealthPolicy) ...HHS is awarding $14 million to the API Innovation Center (APIIC), a St. Louis-based nonprofit, to boost domestic production of key starting materials (KSM) and active pharmaceutical ingredients (APIs) used in essential medications, many of which are currently listed on FDA's drug shortage list. The move is aimed at providing American sourcing for materials that are often produced in China... Sub. Req’d

Who Will Reap The BIOSECURE Spoils? US Industry Boost Not Guaranteed

(9/13, Sarah Karlin-Smith, Pink Sheet) ...Carpenter told the Pink Sheet that Alabama, which is known for manufacturing, could utilize BIOSECURE to strategically advance into biomanufacturing if the right government incentives are included. State and local governments are investing on a bipartisan basis. Carpenter thinks the need for funding can appeal to both Democrats and Republicans nationally because it would represent an economic development and national security win... Sub. Req’d

What Medicare Negotiation Tells Us About Drug Pricing In The U.S.

(9/13, Jennifer C. Chen, Nancy Le, Steve Jang, Anna Kaltenboeck, Health Affairs) ...For this analysis, we created matched "packs" of each of the ten select drugs, based on the size and strength of each that is most utilized in Medicaid and compared those to the same packs sold in countries with publicly available prices, which included Australia, Denmark, and Sweden... Full

FDA Updates Guidance on Classifying ANDA Amendments for GDUFA III

(9/13, Joanne S. Eglovitch, Regulatory Focus) ...This guidance revises a previous version issued in July 2018 and includes some changes to reflect the recent reauthorization of GDUFA. It also addresses comments received in response to a 2022 public docket soliciting feedback on the guidance; FDA received 8 commentsfrom generic drugmakers and the generic drug lobby group the Association for Accessible Medicine. In its request for comments, FDA asked respondents to address Appendix A of the guidance listing the different types of potential major deficiencies... Full

The Greatest Trick the Devil Ever Pulled was Convincing the World He Didn't Exist: Senate Judiciary Set to Mark-Up Patent Reform Bills that Could Significantly Affect Hatch-Waxman and the BPCIA

(9/15, Kurt R. Karst, FDA Law Blog) ...[W]e were recently alerted to the fact that the Senate Committee on the Judiciary has scheduled an Executive Business Meeting for Thursday, September 19, 2024 to mark-up, among other things, two bills of interest: (1) S. 2220, the Promoting and Respecting Economically Vital American Innovation Leadership Act ("PREVAIL Act"); and (2) S. 2140, the Patent Eligibility Restoration Act of 2023 ("PERA Act")... Full

Pharmaceutical Brokers Could Face Regulation by State

(9/16, Don Thomson, Los Angeles Times) ...The proposed law, spearheaded by state Sen. Scott Wiener of San Francisco, a Democrat, would require PBMs to apply for a license by 2027 and would mandate that licensed PBMs pass along 100% of pharmaceutical manufacturers' rebates to health plans or insurers...The Pharmaceutical Care Management Assn., which represents pharmacy benefit managers, said Wiener's bill "blatantly" favors independent retail pharmacies over chains. "This legislation does nothing to lower costs for patients; it simply seeks to financially promote one industry over another with no consumer benefit," the group said... Full

Rx Power Struggle: How Pharma can Flip the PBM Script

(9/13, Steve Stefano, Bill Leonard, Eva Mitchell, Pharmaceutical Executive) ...Given the power and, often argued, one-sided negotiation tactics of the Big 3, what can pharma manufacturers do to level the playing field? Here are several suggestions... Full

Lilly $1.8 Billion Investment to Bolster Irish Manufacturing

(9/12, Catherine Eckford, European Pharmaceutical Review) ...Edgardo Hernandez, Executive Vice President and President of Lilly Manufacturing Operations, explained that the company's new investments will enhance production of medicines for diabetes, obesity and Alzheimer's. The "state-of-the-art facilities will also be equipped to support our promising pipeline molecules of the future"... Full

How Many of Us Will End up Being Diagnosed with ADHD?

(9/14, Catherine Burns, BBC News) ...In other words, we can expect more people to be diagnosed with ADHD now because services are playing catch-up... Full

German Industry Concerned It Will Be Hung Out To Dry By EU Wastewater Directive

(9/13, David Ridley, Pink Sheet) ...A survey by the association has found that Germans want industry to bear the burden of costs for removing micropollutants from wastewater, as set out by the UWWTD – which could reach billions of dollars – but are not prepared to pay more for medicines as a result... Sub. Req’d

Out-of-Pocket Costs for Off-Patent Drugs to Rise in October

(9/15, The Japan Times) ...Under the revised system, patients will shoulder a quarter of the price difference between original and generic drugs in addition to their out-of-pocket expenses, which generally range from 10% to 30% of medical costs... Full

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