Tuesday, March 19, 2024

AstraZeneca Will Cap Inhaler Costs at $35 Per Month

(3/18, Aaron Gregg, The Washington Post) ...Sanders released a statement Monday congratulating AstraZeneca and urging other companies to follow suit. The other two leading manufacturers — GlaxoSmithKline and Teva — have not agreed to a price cap. The lawmakers have pointed to sizable differences in inhaler co-pays between the United States and Europe... Sub. Req'd

AstraZeneca Joins The $35 Inhaler Club; Medicare Patients Waiting On Congress For Membership

(3/18, Alaric DeArment and M. Nielsen Hobbs, Pink Sheet) ...The Federal Trade Commission has also challenged the validity of patents covering a number of drug-device combinations, including BI's inhalers, along with products from AstraZeneca, GSK plc and Teva Pharmaceutical Industries Ltd. Sanders had called out AstraZeneca, GSK and Teva along with BI in an January 8, letter criticizing what he called the "exorbitant" prices of inhalers. And while the company announcements diffuse the immediate political pressure, they may invite calls for more action since they seem to demonstrate that pressure can work... Sub. Req'd

Celltrion Takes Aim At US Infliximab Market With Subcutaneous Launch

(3/18, David Wallace, Generics Bulletin) ...Celltrion has delivered on its long-awaited US launch of its Zymfentra subcutaneous formulation of infliximab, sold in other territories as Remsima SC..."Infliximab is a well-established treatment for people living with ulcerative colitis or Crohn's disease," commented Thomas Nusbickel, chief commercial officer at Celltrion USA. "The novel subcutaneous administration represents an important advancement in patient care that can offer a convenient treatment option, allowing patients in the US to have greater flexibility in managing their disease."... Global Sub. Full

US Aspart Filing Kicks Off Amphastar's Insulin Ambitions

(3/18, David Wallace, Generics Bulletin) ...Amphastar Pharmaceuticals president and CEO Jack Zhang says the firm's recent submission to the US Food and Drug Administration of a biologics license application for insulin aspart "underscores our continued pipeline development in diabetes management, and marks another milestone for Amphastar." Known as AMP-004, Amphastar's proposed rival to Novo Nordisk's Novolog has been submitted with a goal of securing interchangeable status in the US... Global Sub. Full

Dr. Reddy's Laboratories Launches Cancer Treatment Drug in the UK

(3/19, Hormaz Fatakia, CNBC TV 18) ...Dr. Reddy's Laboratories has launched Versavo (bevacizumab) in the UK market, it said in an exchange filing. This is the first biosimilar product of Dr. Reddy's to be approved and launched in the UK market...Bevacizumab, of which Versavo is a biosimilar, is the first antiangiogenic therapy proven to slow metastatic disease progression in patients with cancer... Full

Appeals Court Reverses Novartis Win Over Regeneron in Eylea-Lucentis Battle

(3/18, Zachary Brennan, Endpoints News) ...Regeneron on Monday successfully flipped a lower court's decision in a hotly-contested case against Novartis regarding the companies' competing eye injections...The pivotal issue in the appeal, according to the decision unveiled Monday, was whether anti-VEGF medications in vials and pre-filled syringes compete in the same markets. "The fact that vials and [pre-filled syringes] contain the same medicines and treat the same condition does not automatically mean that they compete in the same market," the appeals court said, siding with Regeneron... Full

Webinar Addresses Solutions to Improve Adalimumab Biosimilar Uptake

(3/18, Skylar Jeremias, The Center For Biosimilars) ...The webinar dubbed "March of the Biosimilars," which was sponsored by Samsung Bioepis and hosted by STAT News, addressed the US launches of 9 adalimumab biosimilars in 2023, which marked the highest number of biosimilars for a single reference product (Humira) to launch within one year. Although uptake has been low so far—only 2% according to Samsung Bioepis' Biosimilar Market Report—, the speakers championed efforts to improve competition and market sustainability... Full

Talks On Another Health Package Broke Down As Spending Deadline Looms

(3/18, Jalen Brown, Bridget Early, Gabrielle Wanneh, InsideHealthPolicy) ...Negotiations between House and Senate leadership on another skinny health package that included pharmacy benefit manager reforms, community health center funding, pandemic response funding and opioid provisions collapsed over the weekend, lowering the chances that health measures will be added to one of the remaining spending bills by the March 22 government funding deadline, according to a senior staffer familiar with the discussions... Sub. Req'd

Brown Calls On Senate Leadership to Act Immediately to Lower Cost of Prescription Medicines

(3/18, U.S. Senator for Ohio Sherrod Brown) ...U.S. Senator Sherrod Brown (D-OH) joined a bipartisan letter to Majority Leader Chuck Schumer (D-NY) and Minority Leader Mitch McConnell (R-KY) to call for immediate action on reforming pharmacy benefit manager practices in an effort to reduce the cost of prescription drug prices and protect access to local pharmacies... Full

Suit Over BI's Orange Book Listing Brings Inhaler Patent Confusion To Courts

(3/19, Maaisha Osman, InsideHealthPolicy) ...Boehringer Ingelheim is facing a class-action lawsuit over patents for its inhalers plaintiffs say are improperly listed in FDA's Orange Book and have prevented market entry of generic products, but an industry lawyer said the lawsuit has a weak basis since it relies on letters from the Federal Trade Commission that say the patents are listed improperly but doesn't challenge the ultimate legitimacy of BI's intellectual property claims...The letters are a component of a broader Senate investigation into the internal decision-making processes of AstraZeneca, Boehringer Ingelheim, GSK and Teva Pharmaceuticals. The investigation aims to unveil the reasons behind the pricing disparity of their inhalers in the United States... Sub. Req'd

Study Suggests Controversial Patent Review Pathway is Effective for Biologics

(3/18, Nicole DeFeudis, Endpoints News) ...In a study published Friday in Nature Biotechnology, the academics argued for the strengthening of the USPTO's review procedures, noting that the pathway "may help promote timely drug competition for the benefit of patients and the US healthcare system."..."This study highlights the need for enhanced examination of biologic patents, potentially creating a stronger post-grant review procedure aimed at identifying and correcting inaccurately granted biologic patents," the report states... Full

US Off-Patent Legislation Could Save Over $1Bn In Ten Years

(3/18, Urte Fultinaviciute, Generics Bulletin) ...Two US bipartisan bills promoting fair off-patent competition and preventing sham petition filing could reduce governmental direct spending by over a billion dollars in the next decade, assuming both bills get enacted in the middle of fiscal year 2024, according to the Congressional Budget Office...The CBO expects that the estimated budgetary effects would mainly stem from "generic drugs or biosimilar biological products entering the market earlier than they would under current law, resulting in lower federal spending for prescription drugs and health insurance subsidies."... Global Sub. Full

Biosimilars Council Commends Nixing ‘Arbitrary' Interchangeability Designation

(3/18, Urte Fultinaviciute, Generics Bulletin) ...At the moment, biosimilars must have an interchangeability label before they can be substituted for the reference brand by pharmacists without the prescriber's involvement, in the same way that generic drugs are, even if there are no meaningful clinical differences from the originator product. "The Biosimilars Council applauds the administration for including biosimilars in their proposed budget," said Craig Burton, executive director of the Biosimilars Council and AAM's senior vice president of policy and strategic alliances... Global Sub. Full

NCPA, Biosimilar Forum Voice Support for PBM Reform Bill

(3/18, Ashley Gallagher, Pharmacy Times) ...Senators Wyden (D-Ore) and Crapo (R-Idaho) are pushing for bipartisan legislation to address practices of Pharmacy Benefit Managers that they believe harm pharmacies and patients. The proposed legislation aims to increase transparency and competition in PBM practices, potentially lowering prescription drug costs for seniors and improving patient access to preferred pharmacies. The National Community Pharmacists Association and the Biosimilars Forum both endorse PBM reform, highlighting negative impacts on pharmacies and patient access to affordable medications... Full

Attacking PBMs Won't Solve Inflation Problem

(3/18, Pat Toomey, RealClearHealth) ...Last week, the Biden administration announced the launch of a joint Federal Trade Commission/ Justice Department "Strike Force" through which, we are told, "President Biden is fighting to lower costs for American consumers—and he is taking action to address corporate price gouging." But, of course, corporate price gouging is not the source of inflation. Reckless overspending and super-easy monetary policy is. And the "Strike Force" attacks on American businesses will likely make the problem worse... Full

Chinese Pharma Group Lobbies Against US Bill Raising National Security Concerns

(3/18, Eleanor Olcott and Wang Xueqiao, Financial Times) ...Chinese pharmaceutical group WuXi AppTec has said it is lobbying hard in Washington against a proposed bill that threatens its business in the US, where it generates 65 per cent of its revenues. "The company has been actively working together with its advisers to set the record straight and advocate for changes to the proposed legislation," Edward Hu, vice-chair and chief investment officer, said in an analysts' call on Tuesday following the release of full-year results... Full

Kentucky Is The Latest State To Enact Legislation To Increase Patient Access To Lower-Cost Biosimilar Medicines

(3/18, Biosimilars Council) ...The Biosimilars Council, a division of the Association for Accessible Medicines, today commended Kentucky for passing and enacting a bill that will increase patient access to lower-cost biosimilar medicines. On March 14, Governor Andy Beshear signed Kentucky House Bill 220 into law, a bill which allows health plans to encourage greater adoption of lower-cost biosimilar medicines, while preventing health plans from abusing step-therapy protocols. Including biosimilars in the Insurance Code provision alongside generics and interchangeable biologics extends patient protections and clarifies the ability for health plans and insurers to encourage adoption of these medications... Full

Colorado is at Odds With The Feds Over Prescription Drug Importation, Documents Show

(3/19, John Ingold, The Colorado Sun) ...Colorado's attempts to import lower-priced prescription drugs from Canada appear to have hit a significant roadblock, according to state documents...According to meeting minutes from a June teleconference between the state and the FDA: "Wholesalers in Canada are not willing to put their businesses at risk by selling without the permission of manufacturers. None of the manufacturers have agreed to such proposals from Colorado so far."... Full

Colorado is The First State Trying to Cap Prescription Drug Costs. But a New Law Could Reel That Back.

(3/18, Angelika Albaladejo, Denver 7) ...In a first-in-the-nation step, a Colorado board is considering setting a maximum cost for an "unaffordable" medication...But some Colorado lawmakers want to reel in the board's power, by limiting which drugs it can review. If passed, SB24-060 would stop the board from considering so-called "orphan drugs." The federal government designates a drug as an "orphan" if it is approved to treat a rare condition affecting less than 200,000 people in the United States. Roughly 400 of the 600 drugs the board has identified for review have orphan drug status for at least one condition, according to the Colorado Consumer Health Initiative... Full

Perscription Drug Affordability Expansion to Wait Until 2025 Session in Maryland

(3/18, Rob Flaks, WMDT) ...Advocates for affordable prescription drugs in Maryland say a major expansion of these state's prescription drug affordability board has been withdrawn in 2024 and will be re-introduced for the 2025 legislative session...Advocates say the setback comes- as the board would have already been setting those prices if a veto from the previous administration did not push back their timing... Full

Tennessee Bill Proposed Would Require Pharmacies to Inform Customers of Lowest Prescription Prices

(3/19, Landon Mion, FOXBusiness) ...The sponsor of the bill, Republican State Rep. Sabi 'Doc' Kumar, said the health system has featured insurers purchasing some pharmacy chains and pharmacy benefit managers while also increasing the price of the medications, according to FOX 17 Nashville. The bill attempts to prevent patients from paying higher co-pays when they can pay for a cheaper product without using their insurance card. The proposed legislation also looks to motivate pharmacists to use a software program that will tell them when a medication is available at a lower cost... Full

EU Patient Groups Say Proposed Definition of ‘Unmet Medical Need' is Too Restrictive

(3/18, Joanne S. Eglovitch, Regulatory Focus) ...Speaking at DIA Europe on March 13, Maria Boulos of the European Medicines Agency, said that that these definitions are now undergoing "extensive discussions" in the European Parliament ahead of a vote on the proposal by the Committee on Environment, Public Health and Food Safety on Tuesday. Other panelists at the session discussed challenges in applying the term to medicines... Full

EMA Decision Time For Aztreonam-Avibactam; High-Stakes Meeting For Lecanamab

(3/18, Neena Brizmohun, Pink Sheet) ...The European Medicines Agency is this week due to decide whether to recommend pan-EU marketing approval for 12 new drugs, including aztreonam-avibactam and insulin icodec, from Pfizer/AbbVie's and Novo Nordisk respectively. In addition, the agency is expected to hold an oral explanation meeting at which Eisai/Biogen can make their case for the EU approval of their Alzheimer's disease drug, lecanemab... Sub. Req'd

All Eyes On Pricing Model As EU Crunch Time Nears For First Ophthalmic Bevacizumab

(3/18, Neena Brizmohun, Pink Sheet) ...If Outlook Therapeutics' Lytenava secures EU approval for wet AMD, the company says it expects to price the drug as a lower cost alternative to biosimilars and premium branded products for the condition, and higher than off-label compounds...In the US, where there are also no approved ophthalmic formulations of bevacizumab, Lytenava has faced a series of obstacles on the regulatory front...Outlook received a further setback in the form of an FDA complete response letter that cited "several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence." Outlook has been taking steps to resolve the FDA's issues and said it expected to resubmit its BLA by the end of 2024... Sub. Req'd

Australia To Give Consumers More Formal Role In HTA Processes

(3/18, Ian Schofield, Pink Sheet) ...The health department says consumers and patients should be able to initiate health technology assessments because many potentially helpful and lifesaving medicines might never be assessed for funding due to "a lack of commercial incentive for pharmaceutical companies."... Sub. Req'd

Sun Pharma Receives Nod to Launch Winlevi in Australia

(3/19, Business Standard) ...Sun Pharmaceutical Industries announced that the Australian Therapeutic Goods Administration has granted regulatory approval for Winlevi (clascoterone cream 1%)...As stated by Hellen de Kloet, Business Head Western Europe, Australia and New Zealand, Sun Pharma Winlevi is an exciting addition to our expanding dermatology portfolio of innovative medicines in Australia... Full

How a Govt Healthcare Scheme is Boosting Pharma Revenues

(3/19, Neethi Rojan, Money Control) ...The pharmaceutical industry in India grew 6.8 percent and had a Rs 1.93 lakh crore turnover in calendar year 2023. This growth was fuelled by the fast growth of domestic branded pharmaceutical companies and a government scheme that promotes the sale of generic drugs. The Rs 10,000-crore generics market forms a small segment of the Indian pharmaceutical market. It is dominated by Cipla, Alkem, and the Jan Aushadhi scheme. The Jan Aushadhi scheme, a central government scheme, aims to provide quality medicines at affordable prices (at least 50 percent cheaper, and in some cases, up to 90 percent cheaper)... Full

Red Sea Shipping Disruptions Don't Have Pharma Companies Seeing Red Just Yet

(3/18, Frank Vinluan, MedCity News) ...The pharmaceutical products that move through the Red Sea are mainly generic drugs manufactured in India, said Jeremy Tancredi, partner and supply chain leader at consultancy West Monroe. Brand name pharmaceuticals are either produced in the U.S. or closer to the U.S., or they are moved by air freight. While air freight is more expensive, the higher margin associated with brand name medicines means a drugmaker can absorb the extra cost, added Pankit Bhalodia, West Monroe's managing director, healthcare & life sciences. "There's enough buffer built in that they can lock in the price for the year and not have significant impact on the margin," Bhalodia said... Full

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