Tuesday, April 9, 2024

FTC's Device Patent Focus May Let FDA Off Hook On Orange Book Clarity

(4/8, Luke Zarzecki, InsideHealthPolicy) ...FTC officials recently put industry on notice it might go after more drug companies than the 10 inhaler makers it recently sent letters to, and on Monday (April 8) again repeated their calls for drug makers to heed their earlier demands to delist what the commission views as sham device patents from FDA's Orange Book...Teva Pharmaceutical's letter also doubles down on its view that it correctly listed its patents. Teva is facing a lawsuit from Amneal Pharmaceuticals based on its Orange Book patent listings on inhaler products, and an amicus brief from FTC argues that Teva recently doubled down on its stance by recertifying its Orange Book listings, which FTC says are based on invalid assumptions... Sub. Req'd

Bill Would Increase Penalty On EpiPen Manufacturers for Flouting Colorado's Price Cap

(4/8, Meg Wingerter, The Denver Post) ...A bill in the Colorado legislature would allow stiffer penalties for EpiPen and insulin manufacturers who refuse to sell their products under the state's price caps, which one generic drugmaker is challenging in court...One manufacturer, Viatris, is complying, while generic drugmaker Teva has sued to end the program...Teva, which sells generic epinephrine auto-injectors for about $300 for a two-pack, has sued the state in federal court, arguing that Colorado's affordability program essentially took private property for public use... Sub. Req'd

Biosimilar Business Recap: BI Layoffs; Teva, mAbxience Partnership; Phase 3 Keytruda Biosimilar Trial

(4/8, Skylar Jeremias, The Center For Biosimilars) ...Teva Pharmaceuticals International—a subsidiary of Teva Pharmaceutical Industries—and mAbxience—a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma—have announced a strategic licensing agreement for a biosimilar candidate targeting multiple oncology indications. The molecule in development was not disclosed, but a statement from Teva said that the company plans to eventually launch the candidate in Europe, the United States, and other global markets... Full

Over a Year After Biosimilars Started Competing, AbbVie Still Holds 96% of Humira Market, Report Says

(4/8, Zachary Brennan, Endpoints News) ...As of February, brand-name Humira controls 96% of the adalimumab market, according to the latest quarterly report from Samsung Bioepis. Biosimilars gained just one percentage point of market share since an earlier version of the Samsung report released six months ago, a stark reminder that real competition for AbbVie's biologic could take years...One recent Iqvia report found that while shifting to adalimumab biosimilars would save up to $6 billion for the US health system, PBMs would lose up to 84% of profit — a major reason very few large payers have come on board... Full

Samsung Bioepis Releases Second Quarter 2024 US Biosimilar Market Report

(4/8, Samsung Bioepis) ...This fifth-edition of the Samsung Bioepis Quarterly Biosimilar Market Report delves into some implications of the Inflation Reduction Act with respect to biosimilars, as well as the biosimilars market share and price trends. "Over the past year, we have strived to provide the US market with the latest biosimilar insights through our report, and we are grateful for the positive reception from our readers," said Thomas Newcomer, Vice President, Head of Market Access, US, at Samsung Bioepis. "As we move forward, Samsung Bioepis remains committed to delivering high-quality, safe, and effective biosimilars. Our goal is to be part of the solution in reducing patients' out-of-pocket expenses, while offering savings to the US healthcare system as a whole." he added... Full

Strides Pharma Receives USFDA Approval for Fluoxetine Tablets

(4/9, Arushi Mishra, The Hindu) ...Strides Pharma Science Ltd has received approval from the United States Food & Drug Administration for its Fluoxetine tabs in 10 mg and 20 mg strengths. The newly approved Fluoxetine tablets are bioequivalent and therapeutically equivalent to the Reference Listed Drug Prozac tablets of Eli Lilly... Full

Lupin Gets USFDA Nod to Market Generic Medication

(4/8, Press Trust Of India) ...Drug firm Lupin on Monday said it has received approval from the US health regulator to market a generic medication to treat involuntary movements caused by tardive dyskinesia. The company has received approval from the US Food and Drug Administration (USFDA) to market Valbenazine Capsules in strength of 40 mg and 80 mg, the Mumbai-based drug firm said in a statement... Full

Purdue Seeking FDA Approval of Auto-Injector for Drug to Treat Opioid ODs

(4/8, David Krechevsky, Hartford Business Journal) ...The Stamford-based biopharmaceutical company said Monday that the FDA has accepted its filing of a new drug application for the auto-injector delivery form of nalmefene hydrochloride injection. If the auto-injector is approved, it would be the second treatment containing nalmefene developed by Purdue to specifically treat the growing number of opioid overdoses nationwide, the company said... Full

Generic Weight Loss Drugs Boosted by UK Approval for Biocon

(4/8, Satviki Sanjay and Advait Palepu, Bloomberg) ...The company, helmed by Kiran Mazumdar Shaw, is leading the charge among Indian drugmakers — the world's largest supplier of generic medicines — as they race to grab a slice of the obesity drugs market. The global frenzy around these medicines has already lured sector giants Sun Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories Ltd., and Cipla Ltd., who are also developing their anti-obesity drugs...Several drug makers are gearing up to launch generic versions of liraglutide this year, including Sandoz Group AG and Teva Pharmaceutical Industries Ltd. Both firms have already settled patent disputes with Novo Nordisk in the US over the launch of generic versions of Victoza, which is liraglutide for type 2 diabetes... Full

Lilly's New $2.5 Billion Plant to Boost Obesity Drug Supply

(4/8, Laura Alviž and Naomi Kresge, Bloomberg) ...The factory will open in 2027 and ship worldwide, the US drugmaker said at the groundbreaking ceremony near Frankfurt on Monday. Lilly is starting work on the plant as its weight-loss blockbuster Zepbound faces shortages in the US and the company races against Novo Nordisk A/S to supply the world with a new generation of injected obesity medicines... Full

Boehringer Ingelheim Taps Sino Biopharm as Chinese Partner for its Emerging Cancer Pipeline

(4/8, Amber Tong, Endpoints News) ...As Boehringer Ingelheim gears up for several potential cancer drug launches over the next few years, it is teaming up with an experienced partner to develop and commercialize those drugs in China. The new alliance with Sino Biopharm covers multiple Boehringer clinical-stage programs, including brigimadlin, an MDM2 inhibitor acting on the p53 pathway; zongertinib, a small molecule HER2 tyrosine kinase inhibitor; and BI 764532, a DLL3/CD3 T cell engager... Full

Perrigo, Investors Settle for $97 Million Over Failed Mylan Bid

(4/8, Peter Hayes, Bloomberg Law) ...Perrigo Co. PLC investors asked a federal trial court for preliminary approval of a $97 million settlement of allegations that the pharmaceutical company overstated its value to fight a takeover attempt by Mylan NV in 2015, leading to a stock drop... Sub. Req'd

USFDA Issues Warning Letter to Natco Pharma for Telangana Plant; Shares Dip Over 2 Percent

(4/9, Financial Express) ...According to the company's regulatory filing, the US Food and Drug Administration had issued eight observations under Form 483 after inspecting the company's Kothur-based formulation facility...It also stated that the company does not believe that the warning letter will have an impact on supplies or the existing revenues from this facility. "It may cause delay/withholding of pending product approvals from this site," Natco Pharma said... Full

Generic Drug Makers Must Close 'Knowledge Gap' to Overcome Doctors' Brand Loyalty: GlobalData

(4/8, Andrea Park, Fierce Pharma) ...That's according to a recent GlobalData survey of nearly 300 healthcare professionals around the world. Almost 40% of those surveyed said they'd stick with brand-name drugs if generics' cost savings were taken out of the equation...The reluctance to prescribe generics found among many of the doctors surveyed may come in part from their wariness toward generics' composition, according to GlobalData... Full

Publix Just Rolled Out a New Way to Cut Prescription Costs. It Involves a New Card

(4/8, Howard Cohen, Miami Herald) ...Publix and its more than 1,200 pharmacies has partnered with a California company to potentially help customers, those with and without insurance, to cut prescription drug costs on many commonly prescribed medications...In April, the Santa Monica-based company announced that Publix has joined its GoodRx Gold network. The card is accepted at Publix pharmacies across eight states in the southeast, including Florida. "If customers are GoodRx Gold members, Publix Pharmacy can process their prescriptions under GoodRx Gold," Publix spokeswoman Lindsey Willis said in an email to the Miami Herald... Sub. Req'd

Congress Returns With A Busy Schedule: Hearings On Physician Pay Reform, Telehealth, Opioids, FDA Policies

(4/8, Amy Lotven, Bridget Early and Dorothy Mills-Gregg, InsideHealthPolicy) ...Congress returns this week to a busy schedule that includes a full Senate Finance hearing that will kick off deliberations on Medicare physician payment reform, a Finance health subcommittee hearing on opportunities to improve care for substance-use disorder, a House Oversight hearing featuring testimony by FDA chief Robert Califf and a House Energy & Commerce health subcommittee hearing on numerous bipartisan bills that aim to support patients' permanent access to telehealth services... Sub. Req'd

Schumer: Senate Could Tackle Insulin, Health Care Costs; Internet Access; Fentanyl With Bipartisan Support

(4/8, Jalen Brown, InsideHealthPolicy) ...Senate Majority Leader Chuck Schumer (D-NY) has an ambitious agenda for the Senate's return to Washington this week that includes lowering costs for prescription drugs like insulin, lowering other health care costs, combatting the fentanyl crisis and expanding internet access to low-income communities. However, Schumer emphasized in a Friday (April 5) Dear Colleague letter that achieving these legislative goals depends on cooperation from his colleagues across the aisle... Sub. Req'd

Senator Brown: Continuing the Fight Against Big Pharma to Lower Insulin Costs

(4/8, U.S. Senator for Ohio Sherrod Brown) ...In 2022, after years of fighting against Big Pharma, we finally took major steps to lower the cost of insulin and other prescription drugs. We passed the Inflation Reduction Act, capping out-of-pocket insulin costs at $35 per month for people on Medicare. Tens of thousands of Ohioans are now saving hundreds of dollars each year because of this price cap. Last week, I met with Ohioans in the Mahoning Valley and heard what a difference the cap is already making for Ohioans on Medicare. Now we need to expand those cost savings to everyone... Full

Health Agency Pushed to License Cancer Drug Patents to Cut Costs

(4/9, Ian Lopez, Bloomberg Law) ...The Biden administration is facing a new call to use its government authority to license an Astellas and Pfizer prostate cancer drug for generic manufacturing. In a Tuesday letter, nongovernmental organization Knowledge Ecology International, Universities Allied for Essential Medicines, and the Union for Affordable Cancer Treatment urged the Department of Health and Human Services to license patents on the drug Xtandi to outside manufacturers to produce lower-cost versions of the drug... Sub. Req'd

Second Opinion: Big Pharma's Out-Of-Pocket Plans On Brand Name Inhalers May Be Designed to Further Undermine Competition

(4/8, The Campaign for Sustainable Rx Pricing) ...Under increasing scrutiny from policymakers and the public for egregious anti-competitive and price-gouging practices on brand name inhalers, several Big Pharma companies, including AstraZeneca, Boehringer Ingelheim and GlaxoSmithKline, recently announced commitments to cap patients' out-of-pocket costs for these products, used to treat asthma and chronic obstructive pulmonary disease. There's one big problem. Big Pharma's decision to "cap" out-of-pocket costs for these drugs is largely a public relations ploy, as drug makers control price, not the details of cost-sharing. In fact, Big Pharma may utilize so-called patient assistance programs as the vehicle for these pledges... Full

PBMs Support Competition and Innovation to Lower Prescription Drug Costs

(4/8, PCMA) ...As the prescription drug marketplace evolves, PBMs continue to innovate to provide a range of coverage options to fit the changing needs of plan sponsors. Employers, including small and mid-sized businesses, value having flexibility and a range of options when designing their prescription drug benefits for the unique needs of their employees. A recent op-ed in Fortune by David Joyner, EVP of CVS Health and President of CVS Caremark, highlights how pharmacy benefit companies encourage greater competition, and explains how PBMs are working to provide choices for businesses to make prescription drug coverage more affordable... Full

The Top Pharmacy Benefit Managers of 2023: Market Share and Trends for the Biggest Companies—And What's Ahead

(4/9, Adam J. Fein, Ph.D., Drug Channels) ...For 2023, nearly 80% of all equivalent prescription claims were processed by three companies: the Caremark business of CVS Health, the Express Scripts business of Cigna, and the Optum Rx business of UnitedHealth Group. Read on for Drug Channels Institute's latest market share figures, along with a preview of the industry changes that will shift these shares over the next few years... Full

Does the Drug Shortage White Paper Fall Short?

(4/9, Kalie E. Richardson, FDA Law Blog) ...Putting aside the question of whether the implementation of any program that requires Congressional action is feasible in the current political climate, we think the underlying premise of the White Paper falls short in both scope and in its description of factors that contribute to drug shortages... Full

Data Integrity: US FDA Guidance Seeks To Head Off Bioavailability/Bioequivalence Study Problems

(4/8, Sue Sutter, Generics Bulletin) ...FDA's new draft guidance is aimed at heading off the types of data integrity concerns with BA/BE studies seen during inspections and drug application assessments. The guidance makes clear that the ultimate responsibility for data integrity rests with the applicant, even if the study is contracted out. Testing site management should build and implement a culture of quality to ensure the integrity of study data... Global Sub. Full

Fighting Accelerated Approval Withdrawal Hinders Other Sponsors' Applications, FDA's Pazdur Says

(4/8, Sue Sutter, Pink Sheet) ...Resource-intensive withdrawal process means FDA reviewers are not able to work on other drugs, Oncology Center of Excellence Director Richard Pazdur says, citing the ‘arduous' withdrawal of Pepaxto. Pazdur also says no one should be surprised that the FDA has begun issuing complete response letters when confirmatory studies are not sufficiently advanced... Sub. Req'd

Gov. Youngkin Vetoes Prescription Drug Affordability Bill Hours Before Deadline

(4/8, Marta Berglund, 13 News Now) ...Gov. Glenn Youngkin's Press Secretary Christian Martinez released the following statement on the veto: "Governor Youngkin embraces policies that make medication available and affordable for Virginians, that's why he signed a bill that provides cost-saving transparency and regulations to the pharmaceutical industry and allows state government to study a plan to import lower-cost prescriptions for Virginians. He rejected a proposal to establish a government price-control board because this policy is not only unproven to lower drug prices it would potentially restrict the access and creation of needed medications and life-saving treatments for families across the Commonwealth."... Full

Commentary: Some States Push Back On Blocking Low-Cost Drug Program — Chris Woodward

(4/9, Chris Woodward, Jacksonville Journal-Courier) ...In recent years, drug manufacturers have declined to offer 340B discounts on their covered outpatient drugs, creating disruption for the patients who rely on them. As the drug industry increases its pressure on the program, some states are fighting back. Arkansas and Louisiana have enacted laws protecting contract pharmacy arrangements. Those laws target manufacturer conditions on the delivery of 340B drugs to contract pharmacies and prohibit them from refusing to supply the discounted drugs. The Virginia legislature just passed a similar law. Major healthcare stakeholders also support the program... Full

Colorado is Trying to Cut Prescription Drug Prices. But Some Patients Fear They Could Lose Access

(4/8, Angelika Albaladejo, Denver 7) ...In a first-in-the-nation step, a Colorado board is considering setting maximum costs for "unaffordable" medications. But some caregivers and patients with rare illnesses are raising concerns the price caps could have unintended consequences — like taking away access altogether. "Everybody wants things to be affordable. But if you just take away the access, that's not okay," said Jennifer Reinhardt, whose daughter has a rare disease...Senators were expected to discuss the bill in recent months, but it has been pushed ahead several times. Lawmakers may be considering changes to the bill before reintroducing it... Full

Britain Must Act or Lose the Global Medicines Competition

(4/9, Mark Samuels, Financial Times) ...The UK is now in a global competition for medicines. Due to a combination of reasons — many self-inflicted — the country's allure as a supply destination is fading fast. Patients are missing critical medicines, and the NHS looks set to lose billions of pounds of vital savings...Whichever party wins the election, we need policies to support the generics sector. Politicians must commit to an industrial strategy that encourages manufacturing, solves regulatory delays and gives manufacturers the certainty they need to return the UK to a priority supply market... Full

EU Health Experts On How ‘Optimization' Could Improve Benefit Of New Cancer Drugs

(4/8, Eliza Slawther, Pink Sheet) ...Innovative new cancer drugs often provide no added clinical benefit when compared against existing therapies, something that could be explained – at least in part – by the fact that these medicines are not being used to treat patients in the best way possible. This is according to several EU health policy experts, including Belgian deputy prime minister and minister of health and social affairs Frank Vandenbroucke and European Medicines Agency executive director Emer Cooke... Sub. Req'd

China's Regulators Accept Jiuyuan Gene's Application For Ozempic Biosimilar

(4/8, Adam Zamecnik, Generics Bulletin) ...China's National Medical Products Administration has accepted Hangzhou Jiuyuan Gene Engineering's marketing application for its semaglutide biosimilar for use in adult type 2 diabetes patients, marking the first filing for a semaglutide biosimilar in the country...In China, semaglutide intellectual property is set to expire in 2026. However, in 2022, the China State Intellectual Property Office ruled all core Novo patents for the product invalid, with Novo filing an appeal at the Beijing Intellectual Property Court... Global Sub. Full

MAIWEIJIAN, First Approved Biosimilar of Denosumab (120mg) in China

(4/8, Mabwell) ...Mabwell, an innovation-driven biopharmaceutical company with entire industry chain, announced that Denosumab Injection (trade name: MAIWEIJIAN, R&D code: 9MW0321) developed by its wholly-owned subsidiary T-mab has officially obtained the marketing authorization approval by National Medical Products Administration (Drug Approval Number: [GYZZ]S20240010). MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China... Full

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