Wednesday, January 17, 2024

Samsung Bioepis Spotlights Slow Adoption of Biosimilars in Q1 2024 Report

(1/17, BNN) ...Samsung Bioepis Co., Ltd. has released its Q1 2024 Biosimilar Market Report, providing crucial insights into the biosimilar industry in the United States. The report outlines the latest pricing data based on the wholesale acquisition cost and average sales price from the Center of Medicare, Medicaid Services...A specific emphasis is placed on the adalimumab market. Despite the launch of nine competitors in a year, the adoption rate of adalimumab biosimilars stands at a meager 2% after six months... Full

Many Entrants But Little Traction in New Humira Biosimilar Market

(1/17, The Pharma Letter) ...The firm said it publishes the quarterly document with the aim of "providing timely information on the current status of biosimilars in the USA." This latest report shows that a total of 45 biosimilars have been approved in the USA, across 14 unique biological molecules, with 38 having been launched in the country. Of these, Humira (adalimumab) is the biologic which has by far attracted the most attention from biosimilar developers, with nine having been approved and launched... Sub. Req'd

Celltrion Launches High-Dose Version of Yuflyma in US

(1/17, Lee Han-soo, Korea Biomedical Review) ...Celltrion said it launched the 80mg/0.8mL dosage form of Yuflyma, a biosimilar referencing Abbvie's Humira (ingredient: adalimumab), in the U.S...The company stressed that considering that over 80 percent of patients in the U.S. who are treated with Humira (the original product) use a high-concentration formulation without citrate, this launch of the 80mg dosage form is expected to increase the preference for Yuflyma significantly... Full

Neuraxpharm Vows Swift Appeal Over Pulled EU Tecfidera Generics

(1/16, David Wallace, Generics Bulletin) ...Neuraxpharm has vowed to rapidly challenge a legal decision that has seen generic rivals to Biogen's Tecfidera (dimethyl fumarate) multiple sclerosis treatment pulled from the market in Europe...Late last year, the European Commission revoked centralized marketing authorizations for generic dimethyl fumarate sold by Neuraxpharm as well as other firms such as Accord, Viatris' Mylan, Polpharma and Teva, following legal action by the originator... Global Sub. Full

Viatris: Symbicort Market Shaping ‘Exactly The Way We Thought'

(1/17, Dean Rudge, Generics Bulletin) ...Although transitioning from its generics foundations, Viatris still has interests in certain complex products. The firm spoke about one, its Breyna generic version of Symbicort, at the recent J.P. Morgan Annual Healthcare Conference..."It's exciting. Again, another first from us," observed Viatris' outgoing president, Rajiv Malik, alluding to Viatris' launch of the first generic version of Advair (fluticasone/salmeterol) in early 2019. "We were in a race and we have been able to launch. The market is shaping exactly the way we thought," he disclosed... Global Sub. Full

Looking Past COPD, Regeneron CSO George Yancopoulos says Dupixent's 'Next Big Thing' is Reversing Allergies

(1/16, Andrew Dunn, Endpoints News) ...George Yancopoulos, Regeneron's chief scientific officer, said Dupixent's potential to reverse severe allergies is the "next big thing" for the biologic that is co-developed by Regeneron and Sanofi. The $102 billion biotech giant expects to start a small proof-of-concept study in humans this year in volunteers with severe food allergies, giving a single dose of an experimental cancer drug followed by regular injections of Dupixent... Full

ANI Pharmaceuticals Announces the FDA Approval and Launch of Indomethacin Oral Suspension, USP

(1/16, ANI Pharmaceuticals, Inc.) ...ANI Pharmaceuticals, Inc. today announced that it received U.S. Food and Drug Administration approval for the Abbreviated New Drug Application for Indomethacin Oral Suspension, USP. ANI's Indomethacin OS is the generic version of the Reference Listed Drug Indocin® Oral Suspension... Full

Sun Pharma, Bayer Partner for Diabetes-Linked Kidney Disease Medicine

(1/17, Nisha Anand, Business Standard) ...Sun Pharmaceutical Industries and Bayer, on Wednesday, announced their partnership to market and distribute a second brand of Finerenone – a medicine meant to treat chronic kidney disease associated with Type-2 diabetes, in India. Sun Pharma, in a regulatory filing, said, "Under the terms of the agreement, Bayer has granted the non-exclusive rights to Sun Pharma to market and distribute a second brand of Finerenone under the brand name 'Lyvelsa'."... Full

Aurobindo Pharma Subsidiary Receives CDSCO Nod for Breast Cancer Treatment Drug

(1/17, CNBC TV 18) ...Aurobindo Pharma Ltd's wholly-owned subsidiary, CuraTeQ Biologics Private Ltd, on Wednesday, January 17, received marketing authorisation from the Central Drugs Standard Control Organization for biosimilar trastuzumab...In another development, Aurobindo Pharma is reportedly exploring the options for the launch of initial public offering of its wholly-owned subsidiary, speciality generic firm Eugia Pharma Specialities, to raise around 4,500 crore in 2024... Full

FDA Urges Court to Dismiss Suit on Generic Sleep Drug Approval

(1/16, Nyah Phengsitthy, Bloomberg Law) ...The Food and Drug Administration opposed Vanda's challenge that the agency disregarded its own policies and was incorrect to approve MSN Pharmaceuticals Inc.'s abbreviated new drug application for a generic version of Vanda's tasimelteon, a drug used to treat non-24-hour sleep-wake disorder...Vanda initially held the only FDA-approved application for a tasimelteon product. However, three other drug companies—Apotex Inc., Teva Pharmaceuticals USA Inc., and MSN—now hold approved ANDAs for generic 20mg tasimelteon capsules... Sub. Req'd

Express Scripts Fueled Opioid Epidemic, Boston Lawsuit Claims

(1/16, Allie Reed, Bloomberg Law) ...Express Scripts Inc. and OptumRX Inc. sought profits over human lives by deceptively marketing opioids and failing to report illegitimate prescriptions, according to a lawsuit brought Friday by the city of Boston. The lawsuit claims the companies violated state and federal controlled substance laws...The challenge follows successful lawsuits holding manufacturers like Purdue Pharma, Teva Pharmaceuticals, Allergan, and Johnson & Johnson accountable for the crisis... Sub. Req'd

More Patients Are Getting Their Meds Online. Big Pharma Wants In On The Action

(1/17, Katie Palmer, STAT Plus) ...Drug manufacturers, mostly smaller ones, have been testing the waters of online platforms that direct patients to "talk to a doctor now" about their drugs as a way to drive sales and sop up patient data. But LillyDirect, which soft-launched in March last year, is the most robust digital offering yet, mirroring growing efforts from the largest pharmaceutical companies to grease the wheels of drug access with telehealth and online pharmacies... Sub. Req'd

Study Highlights Role of Health Plan Type in Biosimilar Adoption

(1/16, Skylar Jeremias, The Center For Biosimilars) ...Low flexibility plans, such as Health Maintenance Organizations and Exclusive Provider Organizations, were more likely to initiate biosimilar therapies than more flexible plans, according to a recent analysis published in PharmacoEconomics. The study highlighted that plan type influences biosimilar adoption for both new-starts and switches from the originator to a biosimilar among US patients, and optimizing plan design to boost biosimilar use could generate savings and improve patient access to medications... Full

Top Pharma CEO Says Preparedness for a New Pandemic Has Not Improved

(1/16, Vicky McKeever, CNBC) ...Vas Narasimhan, CEO of pharmaceutical firm Novartis, told CNBC Tuesday that he didn't believe there had been much improvement in preparedness for pandemics in the wake of the Covid crisis..."Now that we're past the pandemic — and really because of the feats of our industry, companies coming up with incredible mRNA vaccines and diagnostic tools — we're back to almost no investment from governments," Narasimhan said. Without this support, Narasimhan said that companies then also de-invest, with the space potentially lacking investment for 10 to 15 years, and "then we're back in the same place again and a pandemic hits and we're racing."... Full

Drug Importation And Medicaid: Trump Era Guidance Likely Disincentivizes Use

(1/16, Sarah Karlin-Smith, Pink Sheet) ...CMS guidance on the Medicaid Drug Rebate Program, best price and drug importation from 2020 should make it less attractive for states to implement importation programs and help pharma...It is hard to know for sure whether states could get better prices on drugs through importation than through the Medicaid Drug Rebate program, said Edwin Park of Georgetown University's McCourt School of Public Policy Center for Children and Families, but there is reason to think that could be a challenge for states in many cases given the big discounts Medicaid programs already receive... Sub. Req'd

Amicus Briefs Fly in as IRA 'Fair Price' Deadline Looms

(1/16, Nicole DeFeudis, Endpoints News) ...AARP, advocacy groups like Public Citizen and Doctors for America, and researchers employed by leading universities have filed "friend of the court" briefs in support of drug price negotiations under the Inflation Reduction Act. Many of the arguments resemble points made in prior briefs defending the IRA, including ones filed in September in Merck's case. In its brief filed Jan. 12, AARP argued that a ruling in favor of Bristol Myers Squibb "would stop millions of older adults from accessing affordable prescription drugs, threaten the financial integrity of the Medicare program and cost taxpayers billions of dollars."... Full

IRA lawsuits Will Test US' Ability to Regulate Social Pricing in Pharma

(1/16, Isaac Hanson, Pharmaceutical Technology) ...Lawsuits brought by a range of pharmaceutical companies, including AstraZeneca and Johnson & Johnson, against the US Department of Health and Human Services over the Inflation Reduction Act are heating up as the deadline to propose prices draws near and will test the agency's regulatory strength in pricing drugs for social programmes...There is also reason to believe that price negotiations will have limited impacts on the companies currently fighting it. GlobalData analysis shows that nearly all of the drugs affected would still cost close to their launch prices depending on the exact discount negotiated... Full

What to Know About January's Annual Drug Price Hikes

(1/17, Sydney Lupkin, NPR) ...Drug companies often increase prices at the start of the new year, and 2024 seems to be no exception. There have been about 600 price hikes so far in January, according to the drug price nonprofit 46Brooklyn Research..."Since 2016, the pedal to the metal has been kind of pulled back a little bit, where we typically see the weighted average impact of a price increase and the median price increase hovering at around 5%," says 46Brooklyn's CEO, Anthony Ciaccia. That's roughly what he's seeing this year. Ciaccia expects another couple hundred more drug price increases before the end of the month — and that will account for most brand name price hikes this year... Full

New Law Caps Insulin Prices for Some With Diabetes, But Cost Remains High for Others

(1/16, Laura Barro´n-Lo´pez and Shrai Popat, PBS) ...Diabetics will now see a break in their out-of-pocket costs for insulin. Sanofi, one of the leading manufacturers of the hormone, joined two other major pharmaceutical companies in capping their insulin copays at $35. This comes after years of pressure by President Biden, lawmakers and activists for companies to lower their list prices. White House Correspondent Laura Barrón-López reports... Full

Congress to PBMs: Reality Bites

(1/16, Peter Pitts, RealClearHealth) ...The PBM business model thrives on high pharmaceutical list prices. No matter how many times PBM lobbyists claim PBMs lower drug prices, the facts speak for themselves: PBMs consistently choose higher priced medicines over lower priced alternatives for their prescription drug lists because PBM revenue is structured as a percentage of a medicine's list price. That perverse incentive can lead to higher out-of-pocket costs for patients at the pharmacy counter... Full

Don't Blame the Wrong Culprit for Mammoth Healthcare Costs

(1/16, Brian Garst, RealClearHealth) ...Americans care deeply about out-of-control healthcare costs. Eight in ten voters say healthcare affordability is a very important issue to them. Americans want real solutions to this problem, but the drivers of high healthcare costs are frequently misunderstood. Instead of blaming subsidies for Big Pharma and other governments distortions, misguided individuals attack the wrong target. Angela Dingle, the acting president of Women Impacting Public Policy, recently published an op-ed exemplifying this misdirected blame. In the piece, she claimed pharmacy benefit managers are responsible for high drug costs. This take is fundamentally wrong... Full

Just When You Thought the Lisdexamfetamine Shortage Was Over, the Capsule Product Takes Another Hit

(1/16, Bob Pollock, Lachman Consultants) ...Back in August 2023, we reported the approval of a significant number of Lisdexamfetamine ANDAs that we believed would mitigate the ongoing shortage. Today, however, the FDA reported that Lisdexamfetamine capsule dosage-form products are in trouble again. On the list of Lisdexamfetamine Dimesylate Capsule drug shortages are eleven companies, with only two of them reporting availability in all product strengths. Nine of the firms report various levels of limited availability or that the product is on allocation, they have no active ingredient available, that some product will be available in February 2024, or that the product is currently totally unavailable... Full

SCOTUS Chevron Cases Significant For Scope Of CMS, FDA Authority

(1/16, Jessica Karins, InsideHealthPolicy) ...The Supreme Court is set to hear oral arguments Wednesday (Jan. 17) in two cases over the longstanding Chevron deference principle that could have far-reaching consequences for health agencies' ability to interpret statutory language, with a key advocacy group saying the stakes could be high for Medicare drug price negotiation, surprise medical billing and coverage of preventative health care... Sub. Req'd

Warning Letters: Same Old, Same Old at FDA

(1/16, Joanne S. Eglovitch, Regulatory Focus) ...Four warning letters posted earlier this year highlight that everything old is new again when it comes to enforcement problems for the US Food and Drug Administration. Specifically, FDA warned two companies for claiming their human cell and tissue products (HCT/P) can treat diseases or conditions without having an approved biologics license application (BLA), as seen in two recent warning letters. Additionally, the agency issued warning letters to two over-the-counter drug firms – one in the US and one in South Korea – for not testing incoming materials for contamination... Full

Shutdown Prep: US FDA Updates Plan To Furlough More Employees

(1/16, Derrick Gingery, Pink Sheet) ...New FY 2024 plans would retain only 74% of staff, compared to the original, which retained 81%, but still increase the number of workers retained because of user fees. Updated plans indicate the US Food and Drug Administration would furlough substantially more employees than thought at the beginning of fiscal year 2024, potentially adding to the stress on services should the government shut down. Federal agency budgets have been running on a continuing resolution since FY 2024 began on October 1, 2023. FDA funding will run out on January 19, and another CR is in the works that would extend funding to March 1, so negotiations for a full-year funding deal can continue... Sub. Req'd

Editorial: Florida Wants to Import Prescription Drugs. Good Luck

(1/16, Bloomberg) ... Although Florida, according to news reports, will buy medications through wholesale distributors, manufacturers unavoidably control supply. Some have explicit contracts that prevent Canadian wholesalers from reimporting drugs into the US. While states could try to negotiate directly with drugmakers, the industry has little incentive to come to the table, not least because the most significant savings will come from branded drugs with little or no competition. Manufacturers thus have a lot of leverage: They can restrict sales to Canadian wholesalers, creating artificial shortages and raising prices, or find new distributors, who will be loath to lose such lucrative business. That's all before the inevitable barrage of lawsuits... Sub. Req'd

Florida's Plan to Import Drugs from Canada is a Non-Starter

(1/16, André Picard, The Globe and Mail) ...Federal Health Minister Mark Holland has made it clear Canada won't allow the U.S. to put Canada's drug supply at risk. Drug shortages are already commonplace, and large-scale exports would exacerbate the problem...Health Canada, for its part, warned that it could revoke the licence of any manufacturer that causes a drug shortage in Canada by exporting its products. All this is to say that Florida's much-ballyhooed plan to import drugs from Canada is unlikely to happen... Sub. Req'd

A Florida Healthcare Leader says Canadian Imports Will Match the Quality of US Drugs

(1/16, Gabriella Pinos, WFSU) ...Mary Mayhew, president and CEO of the Florida Hospital Association, which advocates for more than 200 hospitals and health systems in the state, spoke about the program Friday with Tom Hudson on The Florida Roundup. She said few Floridians will get the cheaper drugs at first...Before the state imports drugs, however, the Florida Agency for Health Care Administration must send drug information to the FDA for approval, test the drugs, and relabel them to comply with FDA standards. Mayhew said there won't be a difference in quality between the imported drugs and those sold in the U.S... Full

UK's MHRA Faces Questions On Capacity Of New International Recognition Scheme

(1/16, Eliza Slawther, Pink Sheet) ...Members of the MHRA's board of directors have stressed the importance of careful capacity planning following the launch of the UK's new International Recognition Procedure, but the agency claimed there was no "day one rush"...Members of the MHRA's board questioned Julian Beach, the agency's interim executive director of healthcare quality and access, on the IRP progress and the preparedness of the regulator itself during a January 16, board meeting... Sub. Req'd

Oncology Drugs Lead 2023 New Medicines in Europe — EMA Report

(1/16, Lia DeGroot, Endpoints News) ...The European Medicines Agency gave its stamp of approval for 77 new drugs in 2023, with oncology medications leading the pack with the most positive opinions, the agency announced in a report Tuesday. The number of overall positive recommendations was slightly down from previous years, though the number of new active ingredients, 39, was on par with past years, EMA chief medical officer Steffen Thirstrup said on a press call... Full

EMA Approved 77 Drugs, Rejected 3 in 2023

(1/16, Ferdous Al-Faruque, Regulatory Focus) ...The list of drugs approved by the Committee for Medical Products for Human Use includes 39 new active substances, 17 orphan drugs, 8 biosimilars, 15 generics, and 3 drugs that came to market under accelerated assessments. As the world continues to tackle respiratory diseases caused by pathogens such as the SARS-CoV-2 virus and the respiratory syncytial virus, EMA highlighted its work to address emerging diseases and consider novel treatments... Full

GSK Pumps £200M+ Into UK Manufacturing Network to Bolster Commercial Ambitions, API Supply

(1/16, Fraiser Kansteiner, Fierce Pharma) ...As British pharma giant AstraZeneca looks abroad to build new factories, GSK is sticking close to home, where it plans to plug hundreds of millions of pounds into the United Kingdom over the next two years. GSK will lay out more than £200 million (about $253 million) through 2025 to bolster its U.K. supply network, including building new facilities and developing new assembly lines, a company spokesperson said over email on Monday... Full

Sweden Could Reimburse Pharma Industry for Storing More Antibiotics

(1/16, Monica Kleja, Euractiv) ...Shortages and the risk of barely profitable antibiotics disappearing from the Swedish market have led the government to develop a reimbursement model for the storage of new antibiotics, called the Netflix model. Now, authorities are looking at expanding this to older medicines, a version that could be dubbed Netflix 2.0. The details of this model were recently presented in a report by the Swedish Public Health Agency... Full

One of Russia's Largest Generic Drug Production Facilities Planned

(1/16, The Pharma Letter) ...Vyacheslav Kokeladze, a well-known Russian businessman and pharmaceutical tycoon, is investing about 1.4 billion roubles ($20 million) in the establishment of one of the country's largest production facilities for generic medicines. The new business will be known Kronopharm Industries and will build a large-scale pharmaceutical plant in Shchelkovo near Moscow, reports The Pharma Letter's local correspondent... Sub. Req'd

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