Friday, March 15, 2024

Sandoz Benefits From Betting Big On Biosimilars

(3/14, David Wallace, Generics Bulletin) ...Sandoz's biosimilars business was a big earner for the company in 2023. During the firm's Q4 results call, CEO Richard Saynor provided a detailed breakdown of key products in the biosimilars portfolio and pipeline, as he highlighted sales growth of 26% in the most recent quarter. Biosimilars formed a major part of Sandoz's growth story in 2023, with the recently-spunoff company reporting Q4 biosimilars sales that were up by 29% as reported and by 26% at constant currencies to $623m, as full-year turnover from the unit grew by 15% to $2.22bn... Global Sub. Full

Sandoz Celebrates Growth As It Delivers First Standalone Annuals

(3/14, David Wallace, Generics Bulletin) ...An upbeat Sandoz pointed to growth across all its regions and businesses in 2023, as the firm delivered its first annual results as a standalone company...In particular, a 20% leap in Q4 North America sales to $615m - which Sandoz credited to the recent launch of its Hyrimoz (adalimumab-adaz) biosimilar rival to Humira, as well as to the transfer of mature brands from Novartis and strong demand for Omnitrope (somatropin) - helped the region's full-year total to climb by 2% as reported and 3% at constant currencies to $2.13bn, after nine-month results had reflected a slide... Global Sub. Full

Endo's Bleak Financial Reality May See Hope In Spring Amid Potential Restructuring

(3/14, Urte Fultinaviciute, Generics Bulletin) ...Endo reported a 10% decrease in total net revenues in Q4 2023, making a total of $498m compared to $556m in the same period last year. The decrease was primarily attributable to lowered revenues from the off-patent and injectable segments, but partially offset by increased sales in its branded drug business...Despite the decline in revenues, Endo plans to launch five to seven new sterile injectable or generic products this year, according to its Q4 2023 Earnings Report presentation... Global Sub. Full

Coherus Biosciences Cites Biosimilars as Main Drivers of 2023 Revenue Growth

(3/14, The Center For Biosimilars) ...In its earnings report for the fourth quarter and full year of 2023, Coherus Biosciences detailed its rising revenue growth, which it partly attributed to increased sales for its pegfilgrastim and ranibizumab biosimilars...Coherus reported that it hopes the recent launches of its onbody injector for Udenyca (Udenyca Onpro), the first biosimilar competitor to Neulasta Onpro (onbody reference pegfilgrastim), and Loqtorzi (toripalimab-tpzi), a novel melanoma medication, will help offset these challenges... Full

Stada Set To Minimize Xbrane Ownership As Swedish Firm Hunts For Cash

(3/14, Dean Rudge, Generics Bulletin) ..."We are extremely well aware of the consequences for investors that cannot protect their ownership share in this transaction," Xbrane has told its investors, as the Swedish firm looks to tie up much-needed capital injection via a right issue to fuel its pipeline of biosimilar projects. With R&D accounting for more than 80% of its total overheads last year and consistent revenue still in its infancy, fledgling Swedish player Xbrane Biopharma was always likely to head to the markets to seek out more capital, even if such a move would compromise investors by diluting their existing holdings... Global Sub. Full

Bayer Exec: U.S. is Key in Reviving Beleaguered Pharma's Drug Pipeline

(3/15, Allison DeAngelis, STAT Plus) ...In an interview at STAT's headquarters this week, U.S. President Sebastian Guth painted Bayer's previous underinvestment in the U.S. as a positive. "As you look at the IRA, our exposure, given that we've historically been under-indexed in the U.S., our near and midterm exposure is obviously substantially less than it is for other companies," he said... Sub. Req'd

Bristol Myers Nabs New FDA Nod As Breyanzi Brings CAR-T Class to Chronic Lymphocytic Leukemia

(3/14, Angus Liu, Fierce Pharma) ...Breyanzi on Thursday won an FDA accelerated approval for previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma, BMS said. To be eligible for the CD19-targeted CAR-T med, a patient must have tried a BTK drug such as Brukinsa and a BCL2 inhibitor such as AbbVie and Roche's Venclexta. Breyanzi is the first CAR-T cell therapy to enter the CLL/SLL field, where BTK inhibitors are standard first-line treatments... Full

Noramco Launches North American Pharma Supply Chain Services Provider

(3/15, Pharmaceutical Technology) ...Active pharmaceutical ingredients manufacturer Noramco has announced the launch of Noramco Group, a North American pharmaceutical supply chain services provider. It integrates the capabilities of two Noramco subsidiaries: drug product contract development and manufacturing organisation Halo Pharma, and Purisys. The strategic move aims to address the escalating drug shortages and quality concerns in the US by improving supply chain performance and increasing domestic production... Full

Getting the Lay of the Land After a Banner Year for Biosimilars

(3/15, Fran Gregory, PharmD, MBA, Pharmaceutical Commerce) ...When we look at the impact biosimilars are having on healthcare, it's clear that savings are being realized and the landscape is rapidly changing; however, many questions remain unanswered. For example, how will the launch of more biosimilars impact patient choice? What's being done to eliminate regulatory red tape and barriers to access for many of these medications? How much money could biosimilars save the US healthcare system as a whole? Here is a look at where we currently stand in the world of biosimilars... Full

How a Cheap, Generic Drug Became a Darling of Longevity Enthusiasts

(3/15, Daniel Gilbert, The Washington Post) ...The medication has gained a large following thanks to longevity researchers and celebrity doctors who, citing animal studies, contend that rapamycin could be a game changer in the quest to fend off age-related diseases...Researchers have found that rapamycin can modify a kind of cellular communications system that gives cells certain directions — to grow when the body has plenty of food and to slow down when nutrients are scarce. The drug can dial down the signal to grow, causing cells to clear out accumulated junk and allowing them to run more efficiently..."I would say that rapamycin is the current best-in-class for a longevity drug that we have," said Matt Kaeberlein, a professor the University of Washington who has researched rapamycin for two decades and is studying its anti-aging effects in dogs. In his own experience, he credited rapamycin's anti-inflammatory properties with healing his persistent shoulder pain... Sub. Req'd

9 Drugs Now in Shortage

(3/14, Paige Twenter, Becker's Hospital Review) ...As a shortage of penicillin G benzathine injection persists and Mark Cuban's drug company begins producing therapies in short supply, here are nine new shortages, according to national drug supply databases... Full

Taking 'Study Drugs' Like Adderall Could Be Gateway to More Drug Abuse

(3/14, Carole Tanzer Miller, HealthDay News) ...Researchers asked 700 undergraduates across the United States about drugs commonly used by students — including ADHD medications like Adderall, cannabis, nicotine, alcohol, MDMA and ecstasy. They also asked about students' academic performance and physical and mental distress. They found that using one substance appears to prime the brain for using others... Full

Senate Finance Leaders Seek Quick Passage Of PBM Reforms

(3/14, Gabrielle Wanneh, InsideHealthPolicy) ...Senate Finance Chair Ron Wyden (D-OR) and ranking Republican Mike Crapo (ID) said Thursday they hope to get a key pharmacy benefit manager reform bill over the finish line in the next few days, signaling it potentially could be included in upcoming spending legislation that must be passed by March 22 to avoid a partial government shutdown... Sub. Req'd

Lawmakers Amp Up Calls for PBM Reforms to Be Included in Next Week's Funding Package

(3/14, Lia DeGroot, Endpoints News) ...Sens. Ron Wyden (D-OR) and Mike Crapo (R-ID), who helm the Senate Finance Committee, held a press conference Thursday to tout their proposed PBM reforms and hear from patients and independent pharmacists who support the legislation. The unified push comes as Congress is now tasked with passing the next set of appropriations packages by next Friday, after the first round passed earlier this month didn't include any PBM reforms... Full

Senators Aim to Pass Bipartisan Pharmacy Benefits Manager Reform in Government Funding Bill

(3/14, Gabrielle M. Etzel, Washington Examiner) ...The senators also are calling for the addition of the Better Mental Health, Lower-Cost Drugs, and Extenders Act, which the committee unanimously passed last November and builds on MEPA with further reforms to PBMs to cut patients' out-of-pocket costs at the pharmacy counter. The additional bill would provide greater government oversight and accountability for PBMs... Full

CBO Scores E&C PBM Bill After Suggesting Delinking Could Save Less Than Anticipated

(3/14, Gabrielle Wanneh, InsideHealthPolicy) ...The Congressional Budget Office estimates the Protecting Patients Against PBM Abuses Act, a bill the House Energy & Commerce Committee passed in December that aims to delink the compensation pharmacy benefit managers receive from drug makers from prescription drug list prices, would result in a $226 million decrease in the deficit over 10 years, according to cost estimates for several E&C bills published Wednesday (March 13). A separate PBM transparency bill advanced by the committee in December would save more, CBO found... Sub. Req'd

Manufacturers Join Senators' Call for Immediate Action on PBM Reform

(3/14, The National Association of Manufacturers) ...As part of efforts to reduce health care costs for manufacturers and manufacturing workers, the NAM has advocated PBM reform consistently, including in the commercial health insurance market...The NAM supports reforms that will benefit employers by making PBM contracts more straightforward, transparent and predictable and workers by reducing the prices they pay out of pocket for their prescriptions... Full

Biosimilars Forum Urges Congress to Support Free Market Competition and Lower Prescription Drug Prices for Patients by Reforming Pharmacy Benefit Managers

(3/14, Biosimilars Forum) ...Juliana M. Reed, executive director the Biosimilars Forum, released the following statement following a press conference by Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho..."Biosimilars are a commonsense, bipartisan solution to one of the most important challenges facing Americans. The Biosimilars Forum supports patient access to lower cost medicines through free market competition in the pharmaceutical industry. We stand ready to work with both sides of the aisle and the Administration to prioritize patients and provide more choices for lower-cost drugs. Otherwise, the cost-savings promise of biosimilars could be lost forever”... Full

Misguided Proposals Targeting Pharmacy Benefit Companies Would Increase Prescription Drug Costs for Patients, Take Away Options From Health Plan Sponsors, Like Employers and Unions

(3/14, PCMA) ...Proponents of policies targeting pharmacy benefit companies ignore the costly repercussions of undermining pharmacy benefit managers' (PBMs) ability to secure savings that enable health plan sponsors to offer quality, affordable prescription drug benefits. Proposals being pushed to "lower drug costs" that do not address the anti-competitive practices of Big Pharma – which are the root cause of high prices – would do nothing to achieve lower costs. There is a reason Big Pharma supports anti-PBM policies: because they stand to reap higher profits at the expense of patients, plan sponsors and the health care system. Let's take a look at the facts... Full

With Reform Efforts Persisting, PBM Trade Association Sets Lobbying Record

(3/14, Jinghong Chen, Pink Sheet) ...The pharmaceutical and health products industry, which has consistently outspent all other industries on federal campaign contributions and lobbying, spent nearly $378.6 million in 2023 to further policy goals, according to data compiled by OpenSecrets. With the 2024 presidential election around the corner, the pharma/health products industry nearly evenly distributed their donated campaign funds to Democratic and Republican lawmakers during the 2023-2024 election cycle. Among the 20 lawmakers who received the most contributions from the industry, nine are Democrats. President Joe Biden, who is running for re-election this year, topped the list, receiving over $232,000... Sub. Req'd

Cornyn, Bennet Introduce Bill to Lower Prescription Drug Costs for Seniors

(3/14, United States Senator for Texas John Cornyn) ...U.S. Senators John Cornyn (R-TX) and Michael Bennet (D-CO) today introduced the Increasing Access to Biosimilars Act, which would lower prescription drug costs for seniors by promoting competition and encouraging physicians to prescribe biosimilar medications with lower out-of-pocket costs... Full

Former U.S. Patent Head On Why Federal March-In Rights for Drugs Would Be a ‘Devastating' Mistake

(3/14, Michael Gibney, PharmaVoice) ...Despite official backing and support from individual lawmakers, a vocal cadre of detractors, including leaders from the industry, lobbying groups, think tanks and others, want patents to remain in the hands of those who invented a technology, even if it is tied to government funding. One of those detractors is former head of the PTO, Andrei Iancu, appointed to the position under former President Donald Trump. Here's what Iancu, who is also co-chair of the Council for Innovation Promotion, had to say about the proposal and the implications for the industry, as well as the future of drug innovation in the U.S... Full

Risks For Pharma Industry Remain As BIO Shifts Course On BIOSECURE Act

(3/14, Sarah Karlin-Smith, Pink Sheet) ...The legislation's ramifications for US companies could be widespread because of the vast contract research and manufacturing services offered by many of the "companies of concern."...WuXi, for example, reportedly "provides billions of US dollars of services and supplies to the US market each," Ropes & Gray partner Geoffey Lin told the Pink Sheet. The company supplies products and conducts contract research services, so both manufacturing and the conduct of research and trials could be impacted, he said... Sub. Req'd

FDA Warned of Removing Guidance Comment Period in Proposed Plan

(3/14, Nyah Phengsitthy, Bloomberg Law) ...The Food and Drug Administration drew resistance to its draft report and plan for best practices that laid out its intention to issue guidance documents without a notice and comment period...Leading industry groups, manufacturers, and legal experts shared various comments on how the FDA can better its guidance practices, but one common concern among the feedback was that comments are vital for guidance before implementation... Sub. Req'd

Colorado is Proof: Too Many Unanswered Questions Remain About State Government Price Setting's impact On Patients and Providers

(3/14, Reid Porter, PhRMA) ...As the Colorado Prescription Drug Board continues its affordability reviews, too many crucial issues remain unsolved...Several organizations vital to the healthcare system have voiced serious concerns about the board's price-setting measures. But they are falling on deaf ears. Instead, the board's decisions appear to ignore the anticipated consequences of their actions throughout the provider and supply chains as the flawed process moves forward... Full

Alabama Prescription Drug Bill Sparks Debate Over Price Impact

(3/14, Alander Rocha, Alabama Reflector) ...Opponents say the bill could increase costs for consumers and potentially have other long-term impacts. The bill, sponsored by Rep. Phillip Rigsby, R-Huntsville would require that pharmacy benefit managers, third parties that administer pharmacy benefits for health insurance plans, pay pharmacies the price of a prescription set by the state, plus a dispensing fee of $10.64... Full

European Parliament Clears EU-Wide Compulsory Licensing Proposal

(3/14, Ian Schofield, Pink Sheet) ...The draft regulation, which includes a ban on exports of drugs manufactured under an EU compulsory license, will be discussed with the EU member states after the June parliamentary elections...Ahead of the vote, a group of civil society organizations and individuals published an open letter to the parliament stating that an export prohibition was contrary to both the TRIPS flexibilities and to "the EU's position on export restrictions at the WTO."... Sub. Req'd

European Parliament to Dig into Pharma Legislative Revision Next Week

(3/14, Zachary Brennan, Endpoints News) ...The European Parliament's public health committee will meet next Tuesday to discuss and vote on long-awaited legislative fixes meant to encourage more biopharma investment across the EU. The reforms were first unveiled last April, and companies that provide access to their medicines in all European member states would be rewarded with two extra years of data protection. But industry groups like EFPIA have taken issue with the revision, arguing it would effectively penalize companies that cannot make a medicine available across the continent within two years of launch... Full

Experts Discuss Regulatory Approaches for AI and Current Industry Practices

(3/14, Joanne S. Eglovitch, Regulatory Focus) ...The pharmaceutical industry, while in the early stages of incorporating artificial intelligence in drug development, is using AI throughout the product lifecycle. Industry also supports the European Medicines Agency's reflection paper on AI, as it reflects current industry practices, asserted Nicole Mahoney, executive director of global regulatory policy for Novartis, at DIA Europe on March 12... Full

EuroAPI Halts Production at Italian Site as Quality Control Issues Due to ‘Potential' Misconduct Come to Light

(3/15, Anna Brown, Endpoints News) ...EuroAPI is pausing all production at its site in Brindisi, Italy, causing Sanofi's API spinoff to delay its 2024 guidance until the second quarter. "Following an internal audit, quality control deficiencies due to potential local misconduct have been identified and are being further investigated," the company said in a Thursday release. "Production will remain suspended until further notice. The relevant health authorities have been informed. The company has initiated a forensic audit and will inform its customers."... Full

Cost Control Rationale for Pharmacare Does Not Stand Up to Scrutiny: Canadian Health Policy Institute

(3/14, Canadian Health Policy Institute Inc.) ...The latest edition of an annual study from the Canadian Health Policy Institute concludes that the cost control rationale for national pharmacare is not supported by the facts...NDP leader Jagmeet Singh told media that a single payer system is needed to control the cost of new drugs, which are also known as innovative or patented medicines, and that a pharmacare monopsony could negotiate lower prices through "bulk buying". The founder and CEO of the Institute and author of the study, Brett Skinner said, "It is doubtful that a single payer would have substantially more bargaining power because each province already has a monopsony for public reimbursement, and Canada already has a national bureaucracy devoted entirely to controlling the cost of patented medicines."... Full

Prices of 800 Essential Drugs to Increase a Tad from April 1

(3/15, Teena Thacker, The Economic Times) ...After massive annual increases of 12% and 10% in prices on record last year and in 2022, this will be a meagre increase for the pharma industry. The adjusted prices will cover more than 800 drugs on the National List of Essential Medicines. Price changes for scheduled drugs are allowed once a year. Prices of essential medicines including painkillers, antibiotics and anti-infectives are set to see a minuscule increase from April 1... Full

Japan Drug Price Revision: Cuts, Increases Aim To Balance National Healthcare Costs

(3/14, L:isa Takagi, Pink Sheet) ...Japan will raise reimbursement prices for selected essential and clinically valuable drugs in April, while cutting back prices for a higher than usual number of other products through the broad application of market expansion repricing rules. The overall regular revision will see prices cut by 4.7% on average. In a long-running effort to balance growth in national healthcare costs in a rapidly ageing society and promote stability in a flat pharmaceutical market, Japan has announced details of its annual drug reimbursement price revision under the National Health Insurance (NHI) scheme for the fiscal year starting April 1... Sub. Req'd

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