Tuesday, January 28, 2025

Alvotech And Teva Claim First US Golimumab Filing

(1/28, Dave Wallace, Generics Bulletin) ...Thomas Rainey – senior vice president for US biosimilars at Teva – underlined that biosimilars were "ushering a new treatment paradigm and have become an integral staple in the healthcare ecosystem. Teva's strategic partnership with Alvotech underscores our commitment to continue to bring cost-saving options to more patients and deliver better outcomes for those with inflammatory conditions."... Global Sub. Full

FDA Accepts Alvotech's Biosimilar to Simponi (Golimumab) for Review

(1/27, Charlie Sternberg, Contract Pharma) ...Alvotech handles development and manufacturing using its purpose-built end-to-end platform, while Teva is responsible for commercialization in the U.S., which leverages Teva's experience and extensive sales and marketing infrastructure. Since Alvotech and Teva entered into the strategic partnership, two biosimilars developed under the partnership have achieved FDA approval: SIMLANDI and SELARSDI... Full

Samsung Bioepis Doubles Profits After European Ustekinumab Debut

(1/27, Dave Wallace, Generics Bulletin) ...Offering a turnover figure for a portfolio of biosimilars that are sold by third parties through marketing agreements, Samsung Bioepis said "the cumulative Q1-Q3 market sales of six products – biosimilars to Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab), Herceptin (trastuzumab), Avastin (bevacizumab), and Lucentis (ranibizumab) commercialized through partnerships with Biogen and Organon – reached $1.091bn, up 12% year-on-year."... Global Sub. Full

India's Cipla Beats Q3 Profit View as Strong Domestic Demand Offset Weak US Sales

(1/28, Rishika Sadam and Kashish Tandon, Reuters) ...The company's consolidated net profit increased nearly 49% to 15.71 billion rupees ($181.6 million) in the October-December quarter, beating analysts' estimate of 12.12 billion rupees, as per data compiled by LSEG. Revenue from its key India market jumped 10% to 31.46 billion rupees, aided by demand for drugs used to treat respiratory and urology-related conditions...These U.S. sales are usually driven by tumour drug Lanreotide, Cipla's second-biggest revenue generator. However, the company had warned in October that certain supply chain issues related to the drug would last until the fourth quarter... Full

Sage Turns Down Biogen's Buyout Offer and Will Look at Other Options

(1/27, Max Bayer, Endpoints News) ...On Monday, the troubled biotech said its board had unanimously rejected Biogen's $469 million buyout offer, which was $100 million below the amount of cash and equivalents Sage reported at the end of the third quarter. Instead, it will start on a "strategic alternatives" process that could lead to a sale or other deal under different terms. The company said it doesn't have a timeline for the review process and it hasn't decided what action it might take. Goldman Sachs has been tapped to lead the search... Full

Amgen Deal Blocks Celltrion's Bone-Drug Biosimilars Until June

(1/27, Christopher Yasiejko, Bloomberg Law) ...Celltrion Inc.'s biosimilar versions of Amgen Inc.'s blockbuster bone-strengthening drugs Prolia and Xgeva are blocked in the US until June 1 as part of a settlement agreement, according to a filing in New Jersey federal court. Celltrion agreed its biosimilars infringe 29 patents covering denosumab—the active ingredient in both biologics—along with methods of manufacturing it and products containing it, according to a consent judgment and injunction docketed Jan. 24 in the US District Court for the District of New Jersey... Sub. Req’d

Aurobindo Pharma's API Unit in Telangana Gets VAI Status from USFDA

(1/28, Shloka Badkar, CNBC TV-18) ...Aurobindo Pharma on Tuesday, January 28, said the United States Food and Drug Administration has issued an establishment inspection report (EIR) to its subsidiary's active pharmaceutical ingredient facility in Telangana, classifying it as voluntary action indicated (VAI). The Unit 2, API manufacturing facility is of Apitoria Pharma Pvt Ltd, a wholly-owned subsidiary of the company. It is located at Gaddapotharam village IDA, in Sanga Reddy district in Telangana... Full

Obesity Startup Found Drives Weight Loss with Low-Cost Generic Drugs Over GLP-1s, New Study Shows

(1/27, Shelby Livingston, Endpoints News) ...Found, a telehealth startup that treats obesity with medication and lifestyle coaching, unveiled new research showing tens of thousands of its patients lost significant amounts of weight through its program — and most of them used low-cost generic drugs. The company published a peer-reviewed study this month in Obesity Science & Practice that assessed the outcomes of 66,000 Found patients who enrolled between October 2021 and October 2023... Full

Adderall Shortage Sparks Scramble for ADHD Alternatives

(1/27, Dennis Thompson, HealthDay News) ...Adderall prescription fills for children and teens plunged after the U.S. Food and Drug Administration (FDA) announced a shortage of the drug in October 2022, researchers reported in a new study published today in the journal Pediatrics. But at the same time, prescriptions for other types of stimulant drugs used in ADHD treatment increased, according to study results. "Our findings suggest that the Adderall shortage did not cause many children to stop stimulant therapy altogether, but it did force some to switch to alternative stimulants," lead investigator Sijia He, a researcher at the Susan B. Meister Child Health Evaluation and Research Center in the University of Michigan, said in a news release... Full

Drugmakers Show Restraint On Price Increases in New Trump Era

(1/28, Jared S. Hopkins, The Wall Street Journal) ...Drugmakers raised the list prices of more than 800 prescription drugs for blood pressure, cancer and other conditions by a median 4% at the start of this year. The modest size of the annual increases could help companies avoid criticism of gouging from President Trump while seeking his administration's support for such priorities as taking aim at the rebates given to middlemen and altering a federal program providing discounts to certain hospitals. Last year's median price increase was 4.5%. Prices rose on brand-name medicines sold by companies ranging from Pfizer to Novartis and Bristol-Myers Squibb, according to an analysis for The Wall Street Journal by 46brooklyn, a nonprofit drug-pricing research group... Sub. Req’d

AAM: Part D Redesign Leaves Perverse Formulary Incentives, Gaming Potential Unaddressed

(1/27, Gabrielle Wanneh, Inside Health Policy) ...Such changes are necessary, the Association for Accessible Medicines (AAM) says, to prevent pharmacy benefit managers from relying on perverse formulary incentives that are responsible for the slow adoption of generics and biosimilars in Part D despite proven cost-saving benefits for patients and payers across the health care system. The lobby says the new redesign of the Part D benefit, a fixture of the Inflation Reduction Act that kicked off through various changes made effective this year, aims to partially address structural challenges that prevent patients from accessing generics and biosimilars but currently doesn't touch the issue of PBMs preferring the favorable placement of expensive brand medications... Sub. Req’d

Redesigned Medicare Drug Program Still Allows PBMs to Deny Patients Access to Lower-Cost Generics & Biosimilars

(1/27, AAM) ...On behalf of AAM, health consulting firm Avalere examined Part D payer coverage rates for new generics launched between 2016 and 2025. Historical models show Part D plan sponsors coverage rates for first generics lag well behind commercial plan coverage of the same drug products. For example, it appears to take roughly three years before new generics are covered by more than half of all Medicare drugs plans. On the other hand, on average, at least 50 percent of non-Medicare commercial plans typically cover first generic drugs within the year after launch... Full

House Eyes PBM Reform Next Steps

(1/27, Nathaniel Weixel, Joseph Choi and Alejandra O'Connell-Domenech, The Hill) ...House Energy and Commerce Committee leaders are confident the unfinished business of changes to the pharmacy benefit manager (PBM) industry will pass this year, but it's unclear if Democrats will still vote for it. "I would love to see it as it is, in some bill early [in the year]," Energy and Commerce Committee Chairman Brett Guthrie (R-Ky.) told The Hill late last week... Full

NCPA: Independent Pharmacies Weigh Stocking Drugs Under Medicare Price Negotiation

(1/28, Paige Minemyer, Fierce Healthcare) ...In comments submitted on the latest Medicare advance notice, the organization says it conducted a survey of 8,000 pharmacy owners and managers about the drug price negotiation program and found that 93.2% have either decided not to stock drugs under negotiation or are considering not stocking these products. The survey found that 32.8% of independent pharmacists have already made the decision to not stock one or more of the 10 drugs in the first round of negotiations. In addition, 60.4% of those surveyed said they are considering similar steps... Full

RFK Jr. Says He's Open to Seizing Drug Patents

(1/27, Sophia Cai, Adam Cancryn, Irie Sentner and Ben Johansen, Politico) ...Robert F. Kennedy JR. expressed openness to adopting a key progressive proposal for lowering drug prices during a closed-door meeting with Senate Finance Committee staffers, according to three people familiar with the exchange, who were granted anonymity to speak freely about private discussions... Full

Trump Renews Universal Tariff Threat to ‘Protect Our Country'

(1/27, Stephanie Lai, Billy House and Josh Wingrove, Bloomberg) ...President Donald Trump said he wants to enact across-the-board tariffs that are "much bigger" than 2.5%, the latest in a string of signals Monday that he's preparing widespread levies to reshape US supply chains. "I have it in my mind what it's going to be but I won't be setting it yet, but it'll be enough to protect our country," Trump told reporters Monday night... Full

HCSC Tightens Asthma Infusion Coverage, Providers Slam Decision

(1/27, Noah Tong, Fierce Healthcare) ...The insurer posted notices of the policy change in October for Illinois and Texas, set to take effect in March. On the same day Fierce Healthcare sent a list of questions about the policy to HCSC, which has not yet been responded to, the company appeared to delay the policy until mid-April in all impacted states. The policy will apply to its plans in Montana, New Mexico and Oklahoma as well. HCSC said the medical necessity of administering four drugs—Fasenra, Tezspire, Nucala and Xolair—at facilities will be reviewed, requiring members to instead self-administer at home. Medicare, Medicaid and HMO members will not be impacted... Full

US FDA's Accelerated Approval Council: Bigger Role, More Transparency Coming?

(1/27, Sue Sutter, Pink Sheet) ...The HHS Office of Inspector General wants the FDA's accelerated approval council to be more involved in specific product decisions, but the agency said it would complicate a future product withdrawal under the expedited procedures. In 2024, the council discussed increasing transparency about its activities and issues related to withdrawal proceedings. Oncopeptides' Pepaxto was the first product withdrawn under the FDORA procedures, a process that agency officials said is more straightforward, but still consumes a lot of resources... Global Sub. Full

US FDA Opioids Adcomm Postponed; Are Communications Freeze, Travel Ban To Blame?

(1/27, Sue Sutter, Pink Sheet) ...A Trump Administration communications freeze and travel ban may be complicating efforts to convene FDA advisory committees. A February 5, meeting on postmarketing requirements for extended-release/long-acting opioids was postponed, while a February 24, meeting on a Novartis rare disease drug was cancelled... Global Sub. Full

US FDA Senior Staff Return To Office In February, Next Steps for Schedule F Reclassification

(1/27, Sarah Karlin-Smith, Pink Sheet) ... Many non-union FDA employees, including much of its most senior staff, must return to federal offices full time starting February 24,, a new HHS memo says. The FDA will be challenged to find enough space for all staff, but may be able to use the constraints to justify exceptions for employees to continue working remotely... Global Sub. Full

Novo Nordisk to Cap Insulin Prices in Minnesota Settlement; Joins Lilly, Sanofi

(1/27, Jonathan Stempel, Reuters) ...The settlement filed on Monday in the Newark, New Jersey federal court follows similar settlements last year with Eli Lilly and French drugmaker Sanofi. It requires Novo Nordisk to cap out-of-pocket costs for patients who pay with cash at $35 per monthly prescription, regardless of whether the patients have insurance. Novo Nordisk also will provide free insulin to the neediest Minnesotans, defined as those with annual household incomes at or below 400% of the federal poverty level, equivalent to $128,600 for a family of four... Full

Pharmacy Middlemen Lose Bid to Toss New Hawaii Complaint

(1/27, Max Bayer, Endpoints News) ...Judge Leslie Kobayashi of the US District Court for the District of Hawaii denied a motion to dismiss by CVS Caremark, Express Scripts and OptumRx, according to a Friday order. Kobayashi said the rationale was to wait for a hearing to remand the case back to the state court, which is slated for the end of February... Full

How Pharma Can Prepare For Incoming EU Health Data Sharing Rules

(1/27, Eliza Slawther, Pink Sheet) ...The European Health Data Space (EHDS) regulation was formally adopted by the Council of the EU on January 21, and is expected to enter into force in the coming weeks. For pharmaceutical companies, the new legislation will introduce provisions around the secondary use of health data that could impact clinical trial sponsors in particular. The secondary use provisions for health data will become applicable from 2029, meaning that companies have a few years to adapt to the new requirements... Global Sub. Full

Moderna, Novo Nordisk Slammed for Breaching UK Drug Marketing Code Yet Again

(1/27, Nick Paul Taylor, Fierce Pharma) ...Moderna and Novo Nordisk are once again in the bad books of the U.K.'s drug marketing watchdog. The repeat offenders received their latest dressing-downs over a gathering of healthcare professionals and problems with the disclosure of transfers of value, respectively...The latest PMCPA cases yet again accused the companies of bringing discredit on the industry, as indicated by findings of breaches of the ABPI Code of Practice's Clause 2. Novo's case is part of a series of assessments of its problems recording transfers of value to health professionals... Full

Chinese Body Pledges Action Over Quality Concerns

(1/27, Dave Wallace, Generics Bulletin) ...China's National Healthcare Security Administration has responded to reports of complaints from Chinese healthcare professionals about the quality and efficacy of generics purchased through the country's volume-based procurement scheme... Global Sub. Full

Friendshoring: Irish American Supply Chain Examined as a Case Study

(1/27, Patrick Day, Lachman Consultants) ...Using Ireland's actions as a case study is illustrative to the concept of friendshoring. According to the Observatory of Economic Complexity (OEC), using 2022 as a baseline, Ireland has the following trade profile with the U.S. specific to pharmaceutical products: Exports: The Emerald Isle exports USD 83.5B in pharmaceutical products to the United States, accounting for 37% of the exports. Imports: Ireland imports USD 10.9B, with almost 33% of that value being imported from the United States. Others: The next five recipients of Ireland's exports (Belgium, Germany, China, Netherlands, and France) collectively make up approximately the same 37% as exported to the United States... Full

Roll Out of Generic Medicines Pharmacy Scheme Delayed

(1/28, The New Indian Express) ...During his Independence Day address last year, Chief Minister M K Stalin announced that 1,000 pharmacies would be opened across the state under the Mudhalvar Marunthagam scheme from Pongal to sell generic medicines at affordable prices. The launch has been delayed as officials are yet to complete scrutiny of applications and also due to issues in procurement of generic medicines, sources said... Full

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