Wednesday, May 15, 2024

Coherus Positive And Up For The Fight Amid Amneal Pegfilgrastim Deals

(5/14, Dean Rudge, Generics Bulletin) ...Coherus BioSciences insists it is "prepared for any competition if anybody else comes" following Amneal's recent announcement that it has in-licensed two additional pegfilgrastim biosimilar pipeline programs: an on-body injector and a pre-filled autoinjector...Amneal, keen to bolster its offering and capture greater market share, in May last year made its foray into the US pegfilgrastim market by launching its Fylnetra (pegfilgrastim-pbbk) pre-filled single-dose syringe... Global Sub. Full

MS Pharma becomes Partner for the Commercialization of FYB203, Formycon's Biosimilar Candidate to Eylea® (Aflibercept), in the MENA Region

(5/15, Formycon AG) ... Klinge Biopharma GmbH, licensee and exclusive holder of the worldwide commercialization rights for FYB203, Formycon's biosimilar candidate to Eylea®1 (Aflibercept), has entered into an exclusive licensing and supply agreement with MS Pharma for the commercialization of FYB203 in the Middle East and North Africa... Full

After Filing Hitch, Eisai and Biogen Begin Rolling FDA Submission for Subcutaneous Leqembi

(5/14, Fraiser Kansteiner, Fierce Pharma) ...Late Tuesday, the partners said they kicked off a rolling FDA submission for the subcutaneous version of Leqembi—which is currently infused—after securing a fast track designation from the agency. If approved, the under-the-skin formulation would be used to deliver weekly maintenance doses of the amyloid-busting antibody at home or in medical facilities following a biweekly infused initiation phase, Eisai and Biogen said in a release... Full

Granules India Posts Q4 Revenue Fall On Weak Paracetamol Sales, Price Erosion

(5/15, Varun Hebbalalu, Reuters) ...Drugmaker Granules India posted a 1.6% fall in fourth-quarter revenue on Wednesday, hurt by a decline in paracetamol sales and price erosion...Weak sales of the drug and price erosion due to heightened competition hurt its revenue. This is despite analysts expecting Indian API makers, including Granules, to benefit from increasing demand from Europe and the U.S., the industry's biggest markets... Full

Under FDA Scrutiny, Aurobindo's Eugia Tallies a 5th Form 483 in Less Than a Year

(5/14, Joseph Keenan, Fierce Pharma) ...The company's latest slap from the U.S. regulator stems from an April 25 to May 3 inspection of its Bhiwadi sterile drug manufacturing unit in Rajasthan, India, which resulted in seven observations. The majority of the observations were related to workers not following procedures that are intended to prevent microbial contamination or the site lacking manufacturing processes to prevent contamination... Full

US Appeals Court Backs Dismissal Of Bystolic ‘Pay-For-Delay' Case

(5/14, David Wallace, Generics Bulletin) ...Purchaser and payer plaintiffs in the litigation over the so-called "pay-for-delay" deals, including CVS Caremark and Rite Aid, had "fail[ed] to plausibly allege…that any of Forest's reverse payments were unjustified or unexplained," the US Court of Appeals for the Second Circuit concluded, affirming the early 2022 decision of the New York district court to dismiss the claims. Generics firms involved in the case included Hetero, Torrent, Alkem and its Indchemie affiliate, Glenmark, Amerigen and Watson... Global Sub. Full

The Biggest Middleman in the Prescription Drug Supply Chain Now Makes Drugs

(5/14, Lillian Karabaic, Marketplace) ...On April 1, CVS Health entered the specialty drug manufacturing business. Regulators have been taking a hard look at PBMs...In 2023, CVS founded Cordavis, a wholly owned subsidiary of CVS Health, to manufacture prescription drugs. Cordavis' focus is on bringing biosimilar medications to the American market; these are generics for expensive specialty drugs called biologicals. "By 2030, there is a $100 billion opportunity in biosimilars," said Sree Chaguturu, chief medical officer of CVS Health... Full

Biosimilar Use in IBD Still Lags Behind

(5/14, Tony Hagen, Managed Healthcare Executive) ...Inflammatory bowel disease biosimilars have been on the US market since 2016, and biosimilar options have grown significantly, but these lower-cost biologics don't seem to be getting the prescriptions they deserve, according to a 2024 study published in Current Gastroenterology Reports... Full

Cutting-Edge Insulin is Good. But it's the ‘Trailing Edge' of Older Versions that Can Keep it Affordable

(5/15, Robin Feldman, STAT) ...According to Yale researchers, 14% Americans who need insulin to control their diabetes spend more than 40% of their post-subsistence income (what is available after paying for food and housing) on the drug. Many avoid or ration their treatment because of the high cost...Voluntary discontinuation of insulin products has been a consistent trend. It has limited the treatment options for people managing diabetes, pushed them toward more expensive treatments, and prevented biosimilar development for trailing-edge products... Full

As Sales of Weight Loss Drugs Skyrocket, the Insulin Market Falters

(5/15, Karen Fischer, BioSpace) ..."[Novo] can't make a product they're losing money on, which may be the case with some insulins, and at some point they need to be smart with capital," BMO Capital Markets analyst Evan Seigerman told BioSpace...As for the withdrawal of Levemir, Seigerman is of the firm belief that Novo was justified in its decision and not at fault for the lack of a biosimilar. "In the world of pharma, if you have products losing money with no strategic benefit, you have to look at your portfolio and say, is this how we want to use our limited resources? You have to make capital allocation decisions in R&D, manufacturing, and getting the appropriate products to the right patient every time."... Full

How Our Overdose Crisis Response Is Delayed At The Pharmacy

(5/14, Katharine Neill Harris, Health Affairs) ...Several recent changes, long advocated for by substance use experts, can make it easier for individuals to access life-saving care. These include allowing providers to prescribe controlled substances via telemedicine, eliminating the cumbersome X-waiver for doctors to prescribe the medication for opioid use disorder buprenorphine, and approving over-the-counter sale of the overdose reversal drug naloxone. These promising developments, combined with the effective use of national opioid settlement funds, can improve our overdose response strategy dramatically—but only if we address persistent pharmacy-level barriers to care... Full

U.S. Medicines Spending Grew in 2023 as Greater Access Offset COVID-19-related Decline, Says IQVIA Institute

(5/14, IQVIA) ...Overall spending in the U.S. market for medicines grew by 2.5% and reached $435Bn in 2023. Excluding the contribution from COVID-19 vaccines and therapeutics, spending grew at 9.9%, according to a new report from the IQVIATM Institute for Human Data Science, The Use of Medicines in the U.S. 2024: Usage and Spending Trends and Outlook to 2028... Full

Comer, McClain Probe Shortages of Schedule II Drugs, Including Adderall

(5/14, Committee On Oversight and Accountability) ...House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) and Subcommittee on Health Care and Financial Services Chairwoman Lisa McClain (R-Mich.) are furthering their investigation into the growing number of critical drug shortages impacting Americans' medical care. In a letter to Drug Enforcement Administration (DEA) Administrator Anne Milgram, the lawmakers request documents and communications related to DEA's impact on and response to the prolonged shortages of Schedule II drugs, including Adderall... Full

Draft Senate Finance Committee Bill Addressing Drug Shortages Includes Broad Rollback of Medicaid Inflation-Related Rebates for Generic Drugs, Raises Serious Concerns

(5/14, Edwin Park, Georgetown University McCought School of Public Policy) ...Senate Finance Committee Chair Ron Wyden and Ranking Member Mike Crapo have issued their own draft generic drug shortages bill. Unfortunately, like the draft House bill, this bill raises serious concerns..A better alternative than the draft Senate bill's current Medicaid provision would be to provide limited new authority for the Secretary of Health and Human Services to temporarily reduce the Medicaid inflation-related rebate in the case of certain critical high-need generic drugs that are in shortage, suffering from a severe supply chain disruption or determined to likely be in shortage without a reduction of the inflation-related rebate... Full

Lawmaker Accuses Amgen of Placing Profits Above Patients with Dosing for a Cancer Drug

(5/14, Ed Silverman, STAT Plus) ...A U.S. lawmaker is accusing Amgen of "putting profits before patients" over its decision to continue marketing a high dose of a pricey cancer treatment instead of a lower dose that is less expensive and not as toxic to patients. At issue is a medication called Lumakras, which is used to treat non-small cell lung cancer and which won conditional regulatory approval three years ago... Sub. Req'd

FTC Chair Signals Study Of PBM Tactics Remains A Top Priority

(5/14, Gabrielle Wanneh, InsideHealthPolicy) ...Scrutinizing anticompetitive behavior in the health care sector that limits choice of and access to quality care is at the top of the agenda for the Federal Trade Commission, especially cracking down on common business practices used by pharmacy benefit managers that impact the affordability of prescription drugs and threaten the operations of other drug industry stakeholders like pharmacies, FTC Chair Lina Khan said during an interview with MedPage Today Friday (May 10)... Sub. Req'd

Patient Input In US Medicare Price Negotiation: Will CMS Close The Door?

(5/14, Michael McCaughan, Pink Sheet) ..."CMS intends to improve upon the design of the patient-focused listening sessions from initial price applicability year 2026 and is soliciting comments from interested parties on event format, scope, and logistics," the agency said in a draft guidance outlining its plans for the second round of drug price negotiations, which is set to begin in 2025 and will set new prices for up to 15 drugs that will be effective in 2027... Sub. Req'd

Another IRA Surprise: Part B Coinsurance Inflation Adjustments Are Increasing Patient Costs

(5/14, Adam J. Fein, Ph.D., Drug Channels) ...Contrary to what you may have heard, the Inflation Reduction Act's inflation rebates for Medicare Part B drugs do not always save money for seniors... Full

AAM Applauds CMS For Biosimilar Substitution Flexibility In Medicare Part D Plans

(5/14, Urte Fultinaviciute, Generics Bulletin) ...Despite receiving mixed opinions on the Medicare Part D final rule, CMS sees support from the off-patent group AAM, which said that the new policy will have an "immediate impact" on cost reduction and increased access to biosimilars. A more flexible substitution of biosimilars in already approved Medicare Part D formularies will benefit patients by giving "earlier access to equally effective but lower-cost biosimilar treatment options," the Association for Accessible Medicines has told Generics Bulletin... Global Sub. Full

Many Older Voters Still Don't Know About Biden's Signature Drug Price Efforts, Though Awareness Has Grown

(5/15, Tami Luhby, CNN) ...Many older voters remain unaware of the major provisions in the Democrats' Inflation Reduction Act that aim to lower drug costs for Medicare enrollees, according to a new KFF poll released Wednesday. This comes even though the president and others in the administration have highlighted the measures repeatedly, including in new ads running this week...The KFF poll found that 48% of voters ages 65 and older are aware that Medicare has the power to negotiate the price of some prescription drugs. One bright spot for Biden is that share is up from 36% in November... Full

Challenges and Guidance in Biosimilar Assessment: An ISPOR Report On HTA Agency Approaches

(5/14, Skylar Jeremias, The Center For Biosimilars) ...Because of differences in how national authorities that manage drug pricing and reimbursement view health technology assessment tools for biosimilars, there's an urgent need for agencies to issue clear guidance on when and how to conduct HTAs for biosimilars, according to a recent report... Full

Indiana Hospital Prices 8th-Highest in Nation, Study Finds, But Hospitals Dismiss Analysis

(5/14, Whitney Downard, Indiana Capital Chronicle) ...A recent analysis from Kaufman Hall promoted by the hospital association found that Indiana's hospitals had just a 1% operating margin in 2023, compared to national margins of 2.3%. Indiana hospital profits grew more sluggishly than their peers while expenses grew faster. That directly contradicts what another Monday presentation from the National Academy for State Health Policy found. Its presentation, with a focus on its Hospital Cost Tool, found that Indiana's hospitals had higher median net profits than the national average... Full

Chinese Biotech Crackdown Would Reset U.S. Drug Development

(5/15, Maya Goldman, Axios) ...Lawmakers in the House of Representatives on Wednesday are expected to set in motion a massive reordering of how U.S. pharmaceuticals are developed and made, by advancing a contracting ban on five key Chinese research firms...The Senate version of the bill didn't forecast a major effect on drug access or pricing. But the House version could be deemed to hurt drug development and possibly add significant costs to federal programs, said Max Reale, analyst for Compass Point... Full

Oklahoma Attorney General Sues Drug Manufacturers Over Inflated Insulin Prices

(5/14, Alexandra Sharfman and David Chasanov, FOX 25) ...Attorney General Gentner Drummond filed a lawsuit against pharmaceutical manufacturers for unfair prices on Tuesday...The lawsuit is against major diabetic drug manufacturers and pharmacy benefit managers...The cost for the manufacturers that were named in the lawsuit to produce insulin is less than $2 per vial, according to the lawsuit. The drugs, which were once sold for $20 in the late 1990s, now cost between $300 - $700... Full

Pharmacists Applaud Latest State Law Extending Prescribing Rights

(5/14, Gabrielle Wanneh, InsideHealthPolicy) ...As of May 1, Tennessee is the latest of more than 30 states to pass legislation giving pharmacists authority to prescribe drugs for different medication classes and disease states -- authority pharmacists have yet to receive permanently at the federal level despite the expanded roles played by pharmacists in testing for COVID-19 and administering vaccines and treatments, like Paxlovid, during the COVID-19 pandemic... Sub. Req'd

EMA Consults On Using RWD In Non-Interventional Studies

(5/14, Vibha Sharma, Pink Sheet) ...The European Medicines Agency has developed draft recommendations on the key methodological factors to consider when conducting and assessing observational studies with real-world data for regulatory decision-making throughout a medicine's lifecycle... Sub. Req'd

Editorial: Ottawa's Sinking Plan for Drug Price Control

(5/14, The Globe and Mail) ...As Canada's population ages, drug spending will continue to go up. And that's not even including the increasing public spending on drugs that will come from the new pharmacare plan, estimated to start at $1.5-billion a year. If the government is serious about broadening access to medicine, it must start by tackling the price of drugs... Sub. Req'd

New Government's First 100 Days: Pharma Sector Needs Primary Focus

(5/15, Arkaja Goswami, ETHealthWorld) ... As far as India's pharmaceutical industry is concerned, the new government must hit the ground running because the country stands at a critical juncture where strategic focus and policy direction can significantly impact its global standing and domestic healthcare landscape. There are compelling reasons why attention to the pharmaceutical industry which is a knowledge-driven one and a strategic sector, should be a top priority for the new government in its first hundred days... Full

Health: 3,168 Generic Drugs and 46 Biosimilars are Manufactured in Tunisia

(5/14, Tgence Tunis Afrique Presse) ...Director General of the National Agency of Medicines and Health Products, Abdelrazak Hedhili, said, Tuesday that 3,168 generic drugs and 46 biosimilars are manufactured in Tunisia...He also underlined the importance of revising the laws governing the sector, specifying, in this context, that the authorities concerned are currently looking into the revision of Law No. 73 governing the pharmaceutical profession, calling for this purpose the need to review the prices of medicines in Tunisia... Full

AIFA-EGUALIA Meeting. AIFA's President Nisticò: "At Work to Ensure That All Essential Medicines Are Available to Italian Patients"

(5/14, AIFA) ..."The fight against shortages also requires acknowledging the need to make many essential medicines economically sustainable. We have been working on this issue", so AIFA's President, Robert Nisticò at the end of the first meeting with Stefano Collatina, President of EGUALIA (equivalent medicines, biosimilars, value added medicines industries), held at the Agency's headquarters. The need was pointed out to focus attention and efforts on tackling the phenomenon of shortages, so that essential and critical drugs for all chronic therapies, where equivalent and biosimilar drugs are an essential resource, continue to be made available to patients without interruption... Full

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