Wednesday, March 20, 2024

‘Parity To The Originator Is Not Enough' – Cardinal Health Talks US Biosimilars

(3/19, David Wallace, Generics Bulletin) ...Cardinal Health recently published the latest edition of its annual biosimilars report, describing 2023 as "a year of monumental developments in biosimilars," including the launch of the first US rivals to Humira (adalimumab) and an increasing focus on biosimilars in ophthalmology. Following this "pivotal year of evolution and expansion," Cardinal Health's director of biosimilars, Dracey Poore, spoke to Generics Bulletin for an exclusive Q&A... Global Sub. Full

Fresenius And Formycon Strike Stelara Settlement For Europe And Canada

(3/19, David Wallace, Generics Bulletin) ...Fresenius Kabi and Formycon, partners on the FYB202 proposed biosimilar rival to Stelara (ustekinumab), have cleared a path for the product to launch in both Europe and Canada through a settlement agreement with originator Johnson & Johnson. The pair had entered into a global license agreement for FYB202 in early 2023, giving Fresenius Kabi marketing rights "in key global markets following successful approval."... Global Sub. Full

Aurobindo Pharma Shares Rise 2% On USFDA Nod for Nasal Spray

(3/20, Chitranjan Kumar, Fortune India) ...Shares of Aurobindo Pharma climbed over 2% in early trade on Wednesday after the drug maker informed exchanges that it has received US Food & Drug Administration approval for nasal spray. The Hyderabad-based pharma company will manufacture and market Mometasone Furoate Monohydrate Nasal Spray 50 mcg, which will be launched in the first quarter of the financial year 2024-25... Full

Dr Reddy's Labs Launches Versavo Drug in UK

(3/19, Business Standard) ...Dr Reddy's Laboratories said that it has launched Versavo in the United Kingdom for the treatment of several types of cancers. The said drug is equivalent to Avastin...Versavo is the firms first biosimilar product to be approved and launched in the UK. It is available in strengths of 100mg and 400mg single use vials... Full

Takeda's Iclusig Wins First-Line FDA Nod to Treat Rare Philadelphia Chromosome-Positive ALL

(3/19, Kevin Dunleavy, Fierce Pharma) ...Twelve years after Takeda's Iclusig (ponatinib) earned a restricted FDA approval to treat certain patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL), the U.S. regulator has signed off on a wider use. The new endorsement allows the drug to be used with chemotherapy for newly diagnosed, first-line patients with the disorder, Takeda said in a Tuesday release... Full

Drugmaker Endo Receives US Court Approval for Bankruptcy Restructuring

(3/19, Mariam Sunny, Reuters) ...Bankrupt drugmaker Endo International said on Tuesday a U.S. Bankruptcy Court has approved its restructuring plan and related opioid settlements to emerge from bankruptcy, which began in 2022. The company said the transaction is expected to close by late April... Full

Biosimilars Forum Chafes at the Humira Bit

(3/19, Tony Hagen, Managed Healthcare Executive) ...Biosimilars do tend to ramp up over time and capture significant market share from brand name reference product. But that takes about three years, not just one, Samsung Bioepis noted in its report. Still, that isn't enough for the Biosimilars Forum, which is fully aware that with each year that goes by — perhaps each month — AbbVie succeeds in tilting more prescriptions away from Humira and toward its next generation anti-inflammatory products, Skyrizi (risankizumab) and Rinvoq (upadacitinib). That's bad news for the Biosimilars Forum. It means the Humira market overall is shrinking, and biosimilar companies will have to run harder to stay in the same place, market share–wise... Full

Morgan Health, JP Morgan's Healthcare Venture, is Looking to Cut Pharma Costs Next

(3/19, Lydia Ramsey Pflanzer, Endpoints News) ...When it was founded in 2021, the group's initial focus was areas like primary care, analytics and care navigation, Morgan Health CEO Dan Mendelson said, pointing to how 75% of JP Morgan's healthcare costs came from the medical side. "Now that we've established positions in all those areas, we're starting to look a lot more actively at pharma/bio," Mendelson told Endpoints News...In pharma spending, there are three areas where Morgan Health is looking: Specialty drugs (already a top cost for employers), advanced, cell and gene therapies, and GLP-1 medications for weight loss and type 2 diabetes... Full

Drugmakers Give Surprising Response to Medicare Drug Price Offers

(3/20, Joseph Choi, The Hill) ...With the offers remaining secret, some have speculated the price reductions may be relatively modest, but patient groups suspect CEOs may be paying lip service to investors worried about a hit to profits...The Hill reached out to the other companies whose products are being negotiated for comment. Zachary Baron, director of the Health Policy and the Law Initiative at the O'Neill Institute, said these statements reflect the multifront position drugmakers have placed themselves in by suing to stop negotiations while actively remaining engaged... Full

PBM Bills, Other Health Policies Fail to Make Funding Package

(3/19, Michael McAuliff, Modern Healthcare) ...Committee leaders who hoped to build a legislative package around bipartisan PBM measures and other popular items were unable to come to agreement, and Senate and House leadership declined to add healthcare legislation to the fiscal 2024 government funding bill they are expected to release Tuesday or Wednesday... Sub. Req'd

PBMs Continue to Block Patient Access to Lower-Priced Biosimilar Insulin

(3/19, Biosimilars Council) ...This updated report on coverage and utilization management practices by PBMs is consistent with previous analysis conduct by the Biosimilars Council and IQVIA, which found widespread formulary blocks denied patient access to biosimilar insulin. This highlights concerns about PBM decision-making prioritizing the value to payers over the well-being of patients and raises a fundamental question: if lower-cost alternatives are developed, but access is restricted, what is the true benefit...Eliminating incentives for higher-priced drugs and ensuring patient access to biosimilars are crucial steps towards realizing this potential... Full

5 Takeaways from POLITICO's ‘Corrective Action: How to Address Prescription Drug Costs' Event

(3/19, Blake Jones, Politico) ...Those middlemen, the pharmacy benefit managers, came under the microscope Tuesday at "Corrective Action: How to address prescription drug costs," a POLITICO Live event. It was somewhat hostile territory for the industry, featuring its chief antagonist in Sacramento: State Sen. Scott Wiener. Wiener has authored legislation, Senate Bill 966, that would impose new rules on PBMs, represented on the panel by industry advocate Caitlin Berry... Full

US Military at Risk From Reliance On Foreign Drugs, Senators Say

(3/19, Riley Griffin and Anna Edney, Bloomberg) ...In a letter to Pentagon leadership sent Monday, the group led by Democratic Senator Elizabeth Warren of Massachusetts and Republican Senator Marco Rubio of Florida warned of the nation's dependency on foreign countries for crucial medicines. The letter questioned the Defense Department about any drug shortages it's faced, whether they affected service members and were resolved, and other efforts to evaluate risks to the supply chain... Sub. Req'd

Senators Press Department of Defense On Overreliance On Foreign Drug Manufacturers

(3/19, Zachary Brennan, Endpoints News) ...A DOD report, released alongside the letter, shows that 27% of the drugs on the FDA's essential medicines list were categorized by the Defense Logistics Agency as "Very High Risk" because they are either dependent on Chinese manufacturers using Chinese active ingredients or drugs of unknown sources...The report is the product of a section of the 2023 National Defense Authorization Act that directed the DOD to develop guidance for better managing the risk of its pharma supply chain, to report on supply chain vulnerabilities, and to establish a working group to develop policies for allocating scarce pharma resources... Full

After Years of Ransomware Attacks, Health-Care Defenses Still Fail

(3/19, Joseph Menn, The Washington Post) ...Critics say the Change Healthcare fiasco, which has hurt patient care at almost three-fourths of U.S. hospitals, shows that defensive efforts are horribly inadequate. They say a complete response would include strict security requirements for the most critical pieces of the sprawling system, followed by less stringent but still sufficient rules for big hospital systems. The smallest providers, which may not have any security staff, should get help, as called for in the administration's proposed budget. "We need to make sure we know where these vulnerable points are," Nitin Natarajan, deputy director of the Department of Homeland Security's Cybersecurity and Infrastructure Security Agency, acknowledged in an interview. "We're looking at what levers exist."... Sub. Req'd

Proposed FDA Rule Would Prohibit Compounding Of Some Drugs

(3/19, Jessica Karins, InsideHealthPolicy) ...The proposed rule published Tuesday (March 19) seeks to establish criteria for the lists of drug products or categories of drug products that appear on the "Demonstrable Difficulties for Compounding" lists of drugs that do not quality for certain statutory exemptions under the Food, Drug & Cosmetic Act and therefore cannot be compounded at pharmacies. A comment period will be open for 90 days. The proposal would also initially add three categories of drug to the lists: oral solid modified-release drug products that employ coated systems, liposome drug products and drug products produced using hot melt extrusion... Sub. Req'd

Attorney General Announces Lawsuit Against Six Companies Over Insulin Prices

(3/19, Abigail Ruhman, WVPE) ...A new lawsuit alleges six companies conspired to raise insulin prices by 1,000 percent in the last decade. Indiana Attorney General Todd Rokita is suing pharmacy benefits managers and pharmaceutical companies that he said are "dishonest" and harm patients...Rokita announced that the suit includes Sanofi, Novo Nordisk, CaremarkPCS Health, Express Scripts, CVS Health Corporation and Optum Rx. He said these companies made "illegal" profits off of people in need of medications like insulin... Full

Baltimore Sues Eli Lilly, Other Drug Giants Over Cost of Insulin

(3/19, Madeleine O'Neill, The Daily Record) ...The complaint names as defendants drug manufacturers Eli Lilly, Sanofi, and Novo Nordisk, the three dominant insulin suppliers globally, and CVS, Express Scripts, and OptumRx, the three largest pharmacy benefit managers in the United States. In an emailed statement, a spokesperson for Eli Lilly called the complaint "baseless" and pointed to recent actions the company has taken to lower insulin prices...Spokespersons for CVS and Novo Nordisk said they intend to "vigorously defend" against the claims in the lawsuit. Sanofi said its pricing practices have "always complied with the law." Optum said the lawsuit is "without merit." The other companies did not respond to requests for comment Tuesday... Full

Tennessee Bill Proposal Aims to Ensure Lowest Prescription Drug Costs for Consumers

(3/19, Jaclyn Davis, News Channel 9) ...A newly proposed bill in Tennessee could help you get the best price on your medication. The legislation would require pharmacists to tell customers about the lowest prescription drug costs available before any sale is final...We spoke with a local pharmacist Tuesday who understands the benefits of this bill, but says the cost frustration doesn't fall on pharmacists. "The new wrinkle is insurers are purchasing certain pharmacy chains and PBM's," Rep. Sadi Kumar says... Full

EMA Presses On With Keenly-Awaited Guidance On How To Use Patient Experience Data

(3/19, Vibha Sharma, Pink Sheet) ...The European Medicines Agency is making progress with developing its much-awaited reflection paper on the use of patient experience data (PED) in medicines development and regulatory decision-making following a workshop on this topic last year. A draft version of the reflection paper is expected to be released for public consultation by the middle of this year. Also, there are plans to launch a survey in mid-2024 to understand the perceptions, experiences and awareness of PED across therapeutic areas and stakeholders... Sub. Req'd

Interview: EMA's Peter Arlett Provides Update On DARWIN EU

(3/19, Joanne S. Eglovitch, Regulatory Focus) ...This year, DARWIN's data partners generated real-world data (RWD) from 130 million patients in the EU. Peter Arlett, head of the European Medicine Agency (EMA) data analytics and methods task force, sat down with Focus in an interview at the DIA Europe meeting. He spoke about how the use and adoption of RWE has evolved since its establishment in 2022, its uptake by the pharmaceutical industry, and its onboarding of a new data partner that will generate data from health insurance claims... Full

EU Lawmakers Vote to Extend Exclusivity Period for New Medicines, Softening Commission Proposal

(3/19, Tassilo Hummel, Reuters) ...Lawmakers in a EU parliamentary committee on Tuesday voted to extend the exclusivity period for new medicines compared to an initial draft, seeking to address concerns expressed across the bloc's pharma industry as part of a wider regulatory overhaul... Full

European Parliament Committee Adopts Proposals to Revamp Pharma Legislation

(3/19, Nick Paul Taylor, Regulatory Focus) ...The politicians overwhelmingly voted in favor of changes to the current pharmaceutical directive and for the creation of a new regulation. Around 85% of votes were cast in favor of the proposals. Speaking during the vote, Tiemo Wölken, the ENVI rapporteur for the proposed regulations, said that "when we started this mandate, we didn't know that we would be in the middle of the biggest health crisis in the European Union and the world so far." The pandemic shaped Wölken's goals for the proposal... Full

Parliament Compromise On Pharmaceutical Legislation Accelerates Much Needed Reform

(3/19, Medicines for Europe) ...Today, the Members of the Parliament's health committee adopted a compromise position on the EU Pharmaceutical legislation review (comprising of a new Pharmaceutical Directive and Regulation)...Medicines for Europe recognises the hard work of the rapporteurs and of so many highly engaged individual members, as political groups had to move their positions significantly to find a compromise on such a substantial and very complex legislation in near record time... Full

EU Pharma Reform Passes Major Hurdle, With Big Changes To Data Protection Proposals

(3/19, Ian Schofield, Pink Sheet) ...On the face of it, this might seem like welcome news for the R&D-based pharmaceutical industry, which had lobbied strongly against the commission's original proposal...Industry takes a different view. "Despite pragmatic improvements to the initial text, the industry remains concerned that the net impact of the proposals will make Europe less competitive and less attractive as a region for researching and developing medicines and vaccines," said Nathalie Moll, director general of the European pharma industry federation, EFPIA... Sub. Req'd

Pharma Companies Question New EU Incentives As Revamp Advances

(3/19, Zachary Brennan, Endpoints News) ...Industry groups have balked at some of the legislative changes, and on Tuesday reiterated that the changes would make Europe less attractive for pharma investments. "The industry remains concerned that the net impact of the proposals will make Europe less competitive and less attractive as a region for researching and developing medicines and vaccines," EFPIA Director General Nathalie Moll said in an emailed statement to Endpoints News. "It is hard to comprehend how reducing incentives for companies to discover, develop and deliver new treatments in Europe is in the best interests of patients in the region."... Full

Industry To Scrutinize Proposals On Updating Statutory Pricing Agreement

(3/19, Francesca Bruce, Pink Sheet) ...New differentiated repayment rates and new definitions for older and newer medicines are among the proposed updates to the UK's new statutory pricing scheme for branded medicines. On March 19, the UK government began a six-week consultation on the changes required to bring the statutory scheme in line with the voluntary branded medicines pricing, access and growth scheme... Sub. Req'd

Aspire Eyes UK Opportunity From GSK Dropping Fluticasone

(3/19, David Wallace, Generics Bulletin) ...Aspire Pharma says that its UK launch of fluticasone propionate 400mcg 1mg/ml nasal drops "further establishes Aspire as a premier specialty generics business," noting that the product is hitting the market in the wake of GSK pulling out, "leading to a possible short supply for patients."...Moreover, the company noted, the launch follows "a recent discontinuation of fluticasone nasal drops by another manufacturer leading to a possible short supply for patients."... Global Sub. Full

‘Potential Misconduct' Shuts EuroAPI Plant In Italy As 2024 Guidance Suspended

(3/19, Dean Rudge, Generics Bulletin) ...EuroAPI, the Sanofi-spunoff standalone active pharmaceutical ingredient manufacturing business, has suspended its two-week-old 2024 financial guidance after quality control deficiencies due to "potential local misconduct" led it to halt production and sale of all APIs made at the firm's subsidiary in Italy. Deficiencies at the firm's site in Brindisi, 40km north of Lecce, including integrity deficiencies in documentation and quality data related to API quality control, would be further investigated with a "forensic audit," EuroAPI pledged... Global Sub. Full

Lens On Cos Making Drugs, Supplements in Same Facility: Pharma Body Hopeful of a Rethink On Govt Action

(3/20, Teena Thacker, The Economic Times) ...The government is likely to reconsider its recent decision to act against pharmaceutical companies manufacturing nutraceuticals, health supplements and drugs in the same facility following objections raised by industry lobby groups. Federation of Pharma Entrepreneurs (Fope), a pharma lobby group that works with MSMEs, said any clampdown will affect not only exports but also the domestic market... Full

Price of Meds at Public Health Facilities Increased, Health Ministry Bears Costs

(3/20, Junaid Ibrahim, Rahimy Rahim, Allison Lai and Diyana Pfordten, The Star) ...The prices of some medicines and pharmaceutical products at public health facilities have tripled compared to the original, causing the Health Ministry to bear higher costs for drug supplies, says Datuk Seri Dr Dzulkefly Ahmad. The Health Minister said the price hike was multifactorial, mainly due to the unanticipated global situation and procurement systems issue...Among the medicines that were affected include vaccines for Hepatitis B (200%), treatment drugs for tuberculosis (300%), oral rehydration salt (140%) and steroid inhalers (50%)... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: Registration is required to access FirstWord and Generics Bulletin. Click on the links below to register. If you have any questions or issues with access, contact InfoNOW or visit InfoNOW's Industry News page for more details regarding these subscriptions.

                                                         

FirstWord Pharma Plus: Enter your work email address on the Registration page along with your contact information in order to receive access.

  

Generics Bulletin by Informa:

•      Registration: Click on "Sign In" (link on the upper right side of the page). Enter your work email address in the "username" box and press the "Tab" button on your keyboard or click out of the box. You will then be automatically logged into the Informa news resource (no password required). You may be redirected to the Account Settings page to update your contact information.                                

•       Subsequent Access: If you're not automatically logged in, click on "Sign In" (link on the upper right side of the page). Enter your work email address. You will be automatically logged in (no password is required).

•      Note: You must be on the Teva Network (in a Teva location or connected via VPN) in order to access the Informa news resources. You can toggle between the Informa news resources by clicking the news resource on the top.