Monday, August 12, 2024

Biocon Plans to Expand Margins to 25%, Led by New Products and Markets: Group CEO Peter Bains

(8/9, Vaibhavi Ranjan, Money Control) ...Despite facing pricing pressures that squeezed Biocon's operating margins in the first quarter of 2024-25, Group CEO Peter Bains remains confident about the company's growth prospects. In an interview with Moneycontrol, Bains highlighted the robust launch pipeline that he believes will be key to driving Biocon's future success. Building on these expectations, Bains also set a target of 25 percent operating margins for Biocon in the medium to long term... Full

Richter Heralds Xarelto Opportunity As Proof Generics Still Have Life

(8/9, Dean Rudge, Generics Bulletin) ...Hungarian leader Gedeon Richter spoke at length of its recent European roll-out of generic competition to Bayer's Xarelto blockbuster, while also providing key updates for its biosimilar pipeline, as the firm reported financial first-half results. "Those who saw no opportunity in generic small molecules have been, I think, proven wrong by the recent successes in some of these generic launches," Gedeon Richter believes, as it championed the recent launch in European markets of its generic version of Bayer's anticoagulant powerhouse Xarelto (rivaroxaban)... Global Sub. Full

Sandoz Lifts Guidance After Humira Biosimilar Drives Another Quarter of Sales Growth

(8/9, Zoey Becker, Fierce Pharma) ...Now, after reporting second-quarter results, the company said it expects mid- to high-single-digit growth for the year. The company collected $2.6 billion in net sales during the second quarter, representing 9% sales growth compared to the same period last year. The boost was driven by the drugmaker's clutch of biosimilars, which together saw an "exceptional" growth rate of 29%, CEO Richard Saynor said on Sandoz's recent earnings call... Full

Sandoz Bolsters US Ophthalmic Portfolio With Aflibercept Approval

(8/12, David Wallace, Generics Bulletin) ...Sandoz has notched up another US Food and Drug Administration biosimilar approval, this time for its Enzeevu (aflibercept-abzv) rival to Regeneron's Eylea. However, a complicated intellectual property landscape and court proceedings around the ophthalmic brand mean that launch timing remains uncertain. Meanwhile, previous Eylea biosimilar FDA approvals granting interchangeability to other aflibercept sponsors are currently blocking Enzeevu from gaining an interchangeability designation... Global Sub. Full

USFDA Gives Nod to Sandoz's Biosimilar to Treat Eye Disorder

(8/12, Sushmita Panda, Financial Express) ...Enzeevu is a key biosimilar value driver for the company and this approval is a major step in advancing the Sandoz growth strategy by further extending its leading US ophthalmology portfolio. Launch timing will be dependent on several factors, including the progress and outcome of pending or potential future related litigations or any potential settlements... Full

Celltrion Gets FDA Nod for Phase 3 Trial for Keytruda's Copy

(8/12, Dae-Kyu Ahn, The Korea Economic Daily) ...Celltrion Inc., South Korea's biosimilar giant, will proceed with a phase 3 trial for global blockbuster medicine Keytruda's copycat CT-P51, a treatment for non-small cell lung cancer, after obtaining approval from the US Food & Drug Administration, the company announced on Monday... Full

FDA Approves EpiPen Alternative, A Nasal Spray for Anaphylaxis

(8/9, Isabella Cueto, STAT) ...On Friday, the Food and Drug Administration approved the first needle-free treatment for adults and kids with severe allergic reactions. The approval introduces a competitor from ARS Pharma to older epinephrine products, like the EpiPen...ARS presents neffy as a smaller and more easily administered rival to auto-injectors which, for decades, have been the only quick treatment option for people with severe allergies. Epinephrine, which is the same thing as adrenaline, has been used for a century to treat anaphylaxis. However, existing treatments have run into supply, cost, and design issues neffy hopes to fix... Full

US FDA Approves Nasal Spray Alternative to EpiPen for Allergic Reactions

(8/9, Sriparna Roy, Christy Santhosh, Reuters) ...Neffy is expected to be available in the United States within eight weeks of FDA approval, the company said. ARS Pharma will offer neffy at a price of $199 for two doses via digital pharmacy sites like BlinkRx and GoodRx for eligible patients whose insurance plans do not cover neffy. Some commercially insured patients can access the treatment at $25 for each filled prescription of two single-use neffy devices through a co-pay savings program... Full

Purdue, After Playing Major Role in US Opioid Epidemic, Wins FDA Nod for Overdose-Reversal Injection

(8/9, Fraiser Kansteiner, Fierce Pharma) ...This week, the FDA approved Purdue's nalmefene injection Zurnai to treat known or suspected opioid overdoses in adults and kids ages 12 and older. The drug, which comes in a 1.5 mg autoinjector, can be used to treat overdoses from both prescription opioids and synthetic opioids such as fentanyl, Purdue said in a release...The medicine's autoinjector has been designed for ease of use by "anyone in the community," from healthcare professionals and first responders to bystanders, caregivers and family members, Purdue said... Full

Amgen Announces Plans for New Site in India to Strengthen AI, Data and Life Sciences

(8/9, Katherine Lewin, Endpoints News) ...With operations beginning in the fourth quarter, Amgen said Friday that it is opening a new site in Hyderabad, India, with 3,000 employees. Dubbed a tech and innovation facility to "accelerate digital capabilities" to advance Amgen's pipeline, the company said that the new site will strengthen its work around AI and data science, among other areas... Full

Legend Biotech CEO Takes ‘Close Look at Business' Amid Geopolitical Risk, M&A Rumor

(8/9, Angus Liu, Fierce Pharma) ...The company's CAR-T therapy Carvykti, partnered with Johnson & Johnson, is starting a key launch in second-line multiple myeloma, as the two partners are busy expanding capacity at multiple manufacturing sites simultaneously. But lawmakers on the Congress's Select Committee on the Chinese Communist Party recently requested an intelligence briefing on GenScript, which is Legend's largest shareholder and former parent. And the inquiry included Legend, raising fears of a potential BIOSECURE Act-like crackdown... Full

Big Drugmakers Are Clinching Smaller Deals

(8/12, Jared S. Hopkins and Laura Cooper, The Wall Street Journal) ...After shelling out tens of billions of dollars for single biotech companies, pharmaceutical giants such as AbbVie, AstraZeneca and Merck & Co. have shifted to smaller targets costing $5 billion or less. Many of the companies getting taken out are private. The reason, according to executives, bankers and lawyers: Smaller deals are just easier to do in the current regulatory environment, and the sector is looking pretty picked over... Sub. Req'd

Baltimore Reaches $45 Million Settlement with CVS in Opioid Lawsuit

(8/9, Madeleine O'Neill, The Baltimore Sun) ...Baltimore has reached a $45 million settlement with CVS, ending another piece of the city's ongoing lawsuit against major American drug companies and distributors accused of contributing to the opioid crisis...The other companies still in the lawsuit — Johnson & Johnson, McKesson, Cardinal Health, AmerisourceBergen (now called Cencora), Teva Pharmaceuticals and Walgreens — were responsible for more than 80 percent of the opioids sent to Baltimore's pharmacies, the city said... Sub. Req'd

AI and Biosimilars: Bridging Global Health Disparities and Enhancing Treatment Efficiency

(8/10, Skylar Jeremias, The Center For Biosimilars) ...Artificial intelligence (AI) technologies can aid global health systems in incorporating biosimilars into care models, lower health care costs, aid in treatment decision-making strategies, and bridge the gap between high-income and low- and middle-income nations, according to a review published in Pharmaceuticals (Basel)... Full

Senators Warren, King, and Representative Doggett Urge Commerce, HHS to Strengthen and Finalize Guidance on "March-In" Rights to Protect Consumers From High Drug Prices

(8/9, United States Senator Elizabeth Warren) ...U.S. Senators Elizabeth Warren (D-Mass.) and Angus King (I-Maine), and Representative Lloyd Doggett (D-Texas) wrote to Department of Health and Human Services (HHS) Secretary Xavier Becerra and Department of Commerce (Commerce) Secretary Gina Raimondo reiterating their agencies' clear legal authority to use "march-in" rights under the Bayh-Dole Act to lower drug prices for Americans... Full

White House Set to Unveil Medicare Price Negotiation Savings

(8/9, Adam Cancryn and Lauren Gardner, Politico) ...Biden administration officials are expected to disclose the results of the negotiations early on Thursday before the stock market opens because of the impact the news could have on individual companies' stock prices. While it's unclear how specific the officials will get, the government is expected to highlight the savings that patients can expect starting in 2026... Full

OIG: Medicare Paid More for Stelara Under Part D Than Part B

(8/9, Denise Myshko, Managed Healthcare Executive) ...The share of Part D enrollees with coverage for the 10 drugs ranges from less than 60% for Fiasp/NovoLog and 66% for Stelara to 100% for Eliquis, Entresto, Imbruvica, Jardiance, and Xarelto, according to a September 2023 analysis from KFF. At the same time, three biosimilars of Stelara have been approved — Amgen's Wezlan, Samsung Bioepis' Pyzchiva and Alvotech/Teva's Selarsdi — and are expected to be available in 2025 based on licensing agreements with Janssen... Full

Medicare's Opioid Limits Didn't Protect This Doctor's Patients From Deadly Overdoses

(8/10, Mark Maremont, Christopher Weaver, Tom McGinty and Anna Wilde Mathews, The Wall Street Journal) ...Opioid abuse has mushroomed into a national crisis that thus far has defeated all efforts at a solution. In recent years, Medicare set out to limit the abuse of pain medications, but the controls it put in place proved porous and have failed to stop some doctors from prescribing dangerous amounts... Sub. Req'd

IRA Reality Check: Four Strategies for Adapting Hub and Copay Programs

(8/9, Adam J. Fein, Ph.D., Drug Channels) ...As the industry grapples with the realities of price negotiations, inflation penalties, and Part D redesign, manufacturers must adapt their hub and copay programs to ensure continued patient access and affordability... Full

PBMs Continue to Put Profits Over Patients

(8/9, Craig Burton, DC Journal) ...It is clear that this adoption of biosimilars, albeit limited, has benefited patients in the short term. However, a new analysis developed for the Biosimilars Council shows the power of PBMs to drive the adoption of products that benefit the PBM, regardless of whether patients benefit. It remains unclear whether biosimilars are on track for long-term sustainable competition or if this is just the latest mechanism for vertically integrated PBMs to extract value that does not benefit patients... Full

Some ‘Inconvenient' Truths About Pharmacy Benefit Managers

(8/12, T. Joseph Mattingly II, David A. Hyman, and Ge Bai, STAT) ...We write to provide some context on PBMs as authors of an academic study on the subject recently published in JAMA Health Forum, which was cited in the New York Times story and extensively referred to by both the FTC report and House Committee on Oversight report. It is important to clarify three critical facts about the role PBMs play in prescription drug prices and the consequences of various regulatory approaches... Full

The FDA Should Withdraw Approval of More Than 400 Tainted Medicines

(8/12, Suzanne Robotti, STAT) ...When the FDA learned that a testing facility in India had submitted fraudulent data for more than 400 drugs (most of them generics), the agency should have withdrawn them from the market. Instead, it has allowed these drugs to continue to be prescribed and distributed for at least a year as the pharmaceutical companies retest them for equivalency to the original brand-name drugs... Full

FDA Finalizes Guidance On Dose Optimization Studies for Cancer Drugs

(8/9, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration on Thursday finalized guidance to assist sponsors in finding the right dosage for the newer class of cancer drugs. The agency announced that the update stresses there is no "one size fits all approach" in dosing for these drugs... Full

Colorado Drug Board Defends Pay Limits Against Amgen Lawsuit

(8/9, Celine Castronuovo, Bloomberg Law) ...Colorado's prescription drug review board has authority to limit what state-regulated health plans pay for certain drugs, the state attorney general's office wrote Friday in its latest response to a lawsuit from Amgen Inc...An Amgen spokesperson said via email Friday that the company believes "the Board's actions are unconstitutional and we are confident the Court will give careful consideration to the issue. As the litigation proceeds, we remain committed to driving access and affordability solutions for Enbrel patients."... Sub. Req'd

Canada Completes Biosimilar Switching Set With Manitoba Scheme

(8/12, David Wallace, Generics Bulletin) ...Following similar successful biosimilar switching schemes in other regions of Canada, Manitoba has become the tenth and final province to introduce such an initiative. "The Manitoba Biosimilars Initiative will transition provincial drug plan coverage of biologic medications to biosimilar versions, where they are available," the province announced. Patients will need to transition to a biosimilar by January 31, 2025 in order to maintain Pharmacare or other provincial drug plan coverage... Global Sub. Full

England Lags Behind Eight European Countries On Innovative Drug Availability

(8/9, Eliza Slawther, Pink Sheet) ...Both the average rate of availability of new medicines in Europe and the length of time patients have to wait before they can access these drugs increased in 2023 compared with the year before, according to the European pharmaceutical industry federation EFPIA... Sub. Req'd

India Trial Waivers: New Drugs, CGTs Cleared In Specific Countries To Qualify

(8/12, Anju Ghangurde, Pink Sheet) ...India has added a layer of clarity to its clinical trial regulations, indicating that it will consider a waiver of trials for new drugs that have been greenlighted in five specific countries and the EU. In a recent order, the Indian regulator exercised its power under Rule 101 of the New Drugs and Clinical Trial Rules 2019, listing the US, Japan, Australia, Canada, the UK and EU as countries/areas that would be considered for such waivers for specific categories of drugs... Sub. Req'd

NPPA Revises Ceiling Prices of Four Scheduled Drugs Upwards Following DoP Order

(8/10, Pharmabiz.com) ...The National Pharmaceutical Pricing Authority (NPPA) has notified revised ceiling prices of four scheduled drugs, with an upward revision, following review orders passed by the Department of Pharmaceuticals (DoP)... Full

Why Fixed-Dose Combination Drugs Need a Tighter Leash

(8/11, Parth Sharma and Murali Neelakantan, The Hindu BusinessLine) ...The Central Drugs Standard Control Organization (CDSCO) defines FDC drugs as "products containing two or more active ingredients used for a particular indication(s)." The discovery of FDC drugs — once considered to be a step towards better disease control — has now become a huge threat for India's public health system... Sub. Req'd

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