Wednesday, October 23, 2024

Unifying Standards: The Need for Streamlined Biosimilar Development

(10/22, Skylar Jeremias, The Center For Biosimilars) ...Cory Wohlbach, global vice president, biosimilars regulatory affairs at Teva Pharmaceuticals, provided an overview of biosimilar streamlining, focusing on progress made over the past couple years. He highlighted key advancements, such as the removal of animal toxicology testing and improvements in interchangeability status... Full

Accord, Sandoz And Teva Fall To Astellas In $5bn UK Xtandi Patent Challenge

(10/23, Dean Rudge, Generics Bulletin) ...Accord, Sandoz and Teva have suffered setbacks after failing to convince a UK court to revoke the local part of the key European compound patent covering Astellas' Xtandi (enzalutamide) blockbuster treatment for prostate cancer. The trio of generics manufacturers – which did not contest infringement – had argued before UK High Court justice James Mellor that prior art rendered obvious the UK portion of European patent 1,893,196, which expires in June 2028... Global Sub. Full

FDA Expands Indication of Alvotech and Teva's Stelara Biosimilar

(10/22, Don Tracy, PharmExec.com) ...The FDA has approved an additional presentation of Alotech and Teva Pharmaceuticals' Selarsdi (ustekinumab-aekn), a biosimilar to Stelara (ustekinumab). According to Teva, the newly approved solution will be 130 mg/26 mL (5 mg/mL) in a single-dose vial for intravenous infusion. The company stated that the approval will support Selardi in aligning its label with the indications of Stelara, including psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn disease... Full

New Presentation of Ustekinumab Biosimilar Approved for Crohn's, Ulcerative Colitis

(10/22, Victoria Johnson, HCPLive) ...Ustekinumab is a monoclonal antibody which binds to the cytokines interleukin (IL)-12 and IL-23 and is the second biosimilar approved by the FDA stemming from Teva and Alvotech's strategic partnership to collaborate on 7 biosimilars..."We are thrilled with the expansion of SELARSDI's indications, marking another significant milestone in Teva's commitment to increasing access to biosimilars in the US," Thomas Rainey, Senior Vice President, US Biosimilars, added... Full

Teva Pharma (TEVA) PT Raised to $25 at Barclays

(10/23, StreetInsider.com) ...Barclays analyst Balaji Prasad...comments "We introduce our Olanzapine LAI MKt Model, noting TEV-749's sales potential of $1B+. Apart from Mkt potential for TEV-749, another key learning from our call was no monitoring requirements in the label significantly influences market penetration. We also raise our UZEDY est.s to $250M by 2030 (vs $150M earlier."... Sub. Req’d

Teva: Great Time To Buy Leading Generic Drugmaker With Growth Indicators And Lower Debt

(10/23, Albert Anthony, Seeking Alpha) ...In summary, I like Teva for its global diversification and role in reducing drug costs for millions of people through much-needed generics/biosimilars, which evidence points to there being a continued need for. I am confident about upcoming Q3 and Q4 results, expecting continued earnings improvements driven by revenue growth, but think there is more opportunity for the company to speak to what it is doing to reduce costs further... Full

Xbrane In Negotiations For Nivolumab Candidate As It Gets More Time On Deal

(10/22, Dean Rudge, Generics Bulletin) ...In a October 21, update, Xbrane disclosed that it had reached the agreement negotiation stage for its Xdivane (nivolumab) proposed biosimilar to Opdivo, and received the first non-binding proposals on its XB003 proposed biosimilar to UCB's Cimzia (certolizumab pegol)... Global Sub. Full

Amgen Preps to Launch Eylea Biosimilar Years Early After Regeneron Loses Appeal

(10/22, Zachary Brennan, Endpoints News) ...Amgen is moving forward with the launch of Pavblu, its biosimilar to Regeneron's blockbuster Eylea, following an appeals court decision that ruled against competitor Regeneron. "We look forward to bringing Pavblu to patients as quickly as possible to help expand access to affordable and effective treatment," Amgen said in a statement to Endpoints News... Full

Regeneron Loses Bid to Block Amgen's Eylea Biosimilar Launch in US

(10/22, Blake Brittain, Reuters) ..."We continue to believe that Amgen is infringing our patent rights, and today's decision denying our request for a temporary injunction is not the final word in this litigation," Regeneron said in a statement. An Amgen spokesperson said that the company will bring its biosimilar, Pavblu, to patients "as quickly as possible to help expand access to affordable and effective treatment."... Full

Roche Q3 Sales Advance by Forex-adj 9%, Beating Market View

(10/23, Ludwig Burger, Reuters) ...Roche's third-quarter sales gained a currency-adjusted 9%, beating market expectations, on higher prescriptions of once-monthly haemophilia shot Hemlibra and recently launched eye drug Vabysmo...The Swiss drugmaker reaffirmed on Wednesday it expects growth in 2024 adjusted earnings per share in the "high single-digit range", excluding the effect of currency swings and resolution of tax disputes in 2023... Full

Roche Says it is Undeterred by Upcoming Biosimilar Threat to Vabysmo

(10/23, Ayisha Sharma, Endpoints News) ..."We're extremely pleased with the momentum that we see with Vabysmo in the US market and we would expect to see that to continue, especially given that we've just introduced the pre-filled syringe," Roche's pharma chief Teresa Graham said in a media call Wednesday. The company has already seen 80% conversion to the pre-filled syringe from the original vial packaging, she added... Full

Roche Comes Out Against Clearing Takeover of Drug Manufacturer Catalent

(10/23, Ludwig Burger, Reuters) ...The CEO of pharmaceuticals giant Roche has urged authorities to block the takeover of contract drug manufacturer Catalent by Novo Nordisk's controlling shareholder, citing harm to industry peers. "It's not a problem for us, but it could be a problem for other smaller players, if there is a restriction in how many (contract manufacturers) are available," Roche's CEO Thomas Schinecker said in a media call. "From an industry perspective, it would be a wrong decision by authorities."... Full

US FDA Approves Pfizer's RSV Vaccine for Adults at Increased Risk of the Disease

(10/22, Sneha S K, Reuters) ...The U.S. Food and Drug Administration on Tuesday approved Pfizer's RSV vaccine for the prevention of lower respiratory tract disease caused by RSV in adults aged 18 to 59 at increased risk of the disease...CDC's advisers are expected to discuss Pfizer's data at a meeting later this week, but are not expected to vote on whether to expand the recommendation... Full

Purdue Pharma Seeks More Time for Settlement Talks With Sacklers

(10/22, James Nani, Bloomberg Law) ...With mediation at a "fluid and critical juncture," extending the talks, as well as a preliminary injunction protecting Sackler family members from opioid-related litigation, for 35 more days will prevent jeopardizing the ability to achieve a broad consensus, Purdue said in a motion filed Monday in the US Bankruptcy Court for the Southern District of New York... Full

Walmart to Deliver US Prescription Medications in As Soon As 30 Minutes

(10/22, Siddharth Cavale and Ananya Mariam Rajesh, Reuters) ...U.S. retailer Walmart on Tuesday said it will start delivering prescription medicines and medication refills along with groceries and other items as a single order within 30 minutes, upping the ante in its delivery competition against Amazon Inc...Walmart said it decided to launch the service after more than half of respondents in an internal consumer research survey expressed a desire to have prescription medications delivered along with groceries and other items in one order... Full

HHS Touts Part D Cost Cap Savings As Dems Emphasize Drug Costs In Election

(10/22, Gabrielle Wanneh, InsideHealthPolicy) ...As the Biden administration continues to tout cost savings for patients and Medicare achieved through drug price controls implemented under the Inflation Reduction Act just weeks ahead of Election Day, a new report from HHS released Tuesday (Oct. 22) found about 1.5 million Medicare enrollees saved nearly $1 billion on prescription drugs by the end of June this year due to the elimination of cost-sharing in the catastrophic phase of the Part D benefit in January... Sub. Req’d

US Medicaid Programs Say Cost a Key Factor for Weight-Loss Drug Coverage, Survey Finds

(10/23, Amina Niasse, Reuters) ...Most U.S. states do not currently cover highly sought after weight-loss drugs from Novo Nordisk and Eli Lilly in their Medicaid health programs for low income people, citing cost as a key factor, according to a survey conducted by health research firm KFF... Full

Weight Loss Drug Coverage Will Not Pay For Itself, US CBO Affirms

(10/22, Michael McCaughan, Pink Sheet) ...The US Congressional Budget Office acknowledged that weight loss drug coverage could drive long term savings from ancillary health issues, but not enough to offset the cost of the drugs. Expanding Medicare coverage would cost the US Treasury $35 billion over 10 years...Savings on other health costs were estimated at $3.4bn during the first decade of expanded coverage, while the cost of the drugs was $38.8bn. The estimates also assumed a significant reduction in GLP-1 costs due to Medicare price negotiation... Global Sub. Full

'It's Not Right.' Califf Slams Pharma Over Weight Loss Drug Prices

(10/22, Nicole Wetsman, Endpoints News) ...Califf, who's previously called out high drug prices, said the weight loss and diabetes medication shortages were — to his knowledge — the first time a company was unable to produce enough of a drug sold at a high, profitable price point to meet the demand. Semaglutide is currently in shortage, while the FDA in October took tirzepatide off its shortage list... Full

Novo Asks FDA to Bar Compounders from Making Ozempic Copies

(10/22, Elaine Chen, STAT Plus) ...Novo Nordisk has asked the Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make...The Alliance for Pharmacy Compounding was quick to respond to Novo's request. Scott Brunner, CEO of the trade group, posed the question that if Novo is concerned about patient safety, why has it taken them so long into the shortage to nominate semaglutide to the difficult to compound lists... Sub. Req’d

Senators Question Whether Pfizer, Eli Lilly Telehealth Platforms Violate Law

(10/22, Nicole DeFeudis, Endpoints News) ...A Lilly spokesperson told Endpoints News on Tuesday that its telehealth partners are "fully independent from Lilly, exercise autonomous clinical judgment in evaluating and making care decisions, are not incentivized to prescribe Lilly medicines and do not provide any compensation to Lilly for referrals."... Full

Q&A: Mark Cuban Explains His Beef with Traditional PBMs — And Why He Thinks They're Destined to Fail

(10/23, STAT) ...Cuban recently joined STAT's Torie Bosch and Matthew Herper on the First Opinion Podcast to discuss his views on PBMs and the rest of the health care system... Full

BIOSECURing the Future: What an American Cold War with China Could Mean for the Pharma Industry

(10/22, Nielsen Hobbs, Pink Sheet) ...Regardless of whether BIOSECURE passes this year, the pharma industry's involvement in China will continue to face political scrutiny. Sponsors continue to take a "wait and see" approach about the potential impact of legislation on operations. Significant "reshoring" of pharmaceutical manufacturing would require government investments that themselves would depend on additional legislation... Global Sub. Full

AAM Brief Look Back at Day One and Some Thoughts On Day Two

(10/22, Bob Pollock, Lachman consultants) ...Day Two at GRx-Biosims, Dr. Sarah Yim, Director of the Office of Therapeutic Biologics and Biosimilars, had a fireside chat with Giuseppe Randazzo, Senior Vice President, Sciences and Regulatory Affairs, at AAM. The takeaway from the session was that, with few exceptions, the Agency, based on experience post approval, the advancement of analytical and scientific testing, and a "groundswell of information that tells us that we can streamline the approval process," gives the FDA confidence that biosimilar are interchangeable... Full

GRx+Biosims: Panelists Discuss Regulatory Shifts in Biosimilar Interchangeability

(10/22, Skylar Jeremias, The Center For Biosimilars) ...Arlene Wolny, PhD, global head of regulatory affairs, Biocon Biologics, provided an industry perspective, addressing the historical concerns about immunogenicity. She outlined how requirements for obtaining interchangeability impacted stakeholders, often creating confusion and high entry barriers... Full

Maryland's Drug Affordability Board is a Step Closer to Setting Prescription Caps

(10/22, Mary Kekatos, ABC News) ...The Maryland Prescription Drug Affordability Board -- which drafted the Upper Payment Limit Action Plan -- presented before the Legislative Policy Committee on Tuesday morning, saying caps will help increase affordability and increase access...The plan would then establish a set of criteria for the state to negotiate with companies that are charging such prices for drugs that are at least partially covered by state insurance plans... Full

Cost Cannot Be Ignored by Drug Board – Just Ask the Patients Who Can't Afford Prescriptions

(10/22, Gerard F. Anderson, Maryland Matters) ...The data I reviewed as a member of the Maryland PDAB shows that the Medicaid program is paying significant amounts for each of these six drugs and the state is paying a large amount for each of these drugs to provide health insurance for state and county employees. Paying high prices for these drugs significantly limits access to these drugs and requires the state of Maryland to make difficult policy choices. Numerous studies have shown that 40% of the public has not filled a prescription because of the high costs of their prescription drugs... Full

World-First Medicine Manufacturing Regulatory Framework to Be Implemented

(10/22, Catherine Eckford, European Pharmaceutical Review) ...The UK is set to be the first country to introduce a new regulatory framework for innovative products manufactured at or close to the point of patient care, says the Medicines and Healthcare products Regulatory Agency (MHRA). This Statutory Instrument means that patients can access highly personalised medicines and medicines with a very short shelf life more quickly... Full

EU Needs ‘Agile & Enabling Ecosystem' To Address Decline In Clinical Trials

(10/22, Ian Schofield, Pink Sheet) ...The EU Clinical Trials Regulation has "so far failed to improve Europe's competitiveness," according to a new report commissioned by the pharmaceutical industry body EFPIA...The diminishing attractiveness of Europe for clinical research can be attributed to less favorable regulatory and funding environments, with Germany and Belgium seeing a significant slowdown in trial activity. EFPIA has called for member states and the European Commission to take action to build up clinical trial capacity, improve the trials infrastructure and reduce bottlenecks... Global Sub. Full

As Deadline Looms, BGMA Sounds Alarm Over Northern Ireland Requirements

(10/22, Dave Wallace, Generics Bulletin) ...With a looming deadline of January 1, 2025 for firms supplying Northern Ireland to comply with the Windsor Framework, UK generics and biosimilars association the BGMA has warned of potential supply interruptions due to requirements that include a "UK only" label for all packs as well as UK-based batch testing for biologicals... Global Sub. Full

UK Approves Lilly's Alzheimer's Drug, But Deemed 'Too Expensive' for Wide Use

(10/23, Prerna Bedi, Shanima A and Bhanvi Satija, Reuters) ...Eli Lilly's treatment for early Alzheimer's was deemed too expensive for wide use by UK's cost-effectiveness body on Wednesday, signalling that patients are unlikely to get access following approval by the country's medicines regulator...Lilly said it remains confident in the cost-effectiveness of donanemab and will work closely with NICE during the consultation period, which ends on Nov. 20... Full

U.K.'s Cost-Effectiveness Agency Says Alzheimer's Drug Donanemab Does Not Provide Good Value

(10/23, Andrew Joseph, STAT Plus) ...The draft guidance from NICE came the same day that the U.K.'s regulatory agency announced it had approved donanemab for patients with early Alzheimer's. But a positive review from NICE is typically required if a drug is going to become available in the NHS. "I know this will be disappointing news, but this is an emerging field of medicine and there are other treatments being developed," Helen Knight, NICE's director of medicines evaluation, said in a statement... Sub. Req’d

Nordic HTA Collaboration: Feel the Fear And Do It Anyway

(10/22, Francesca Bruce, Pink Sheet) ...Pharmaceutical companies have been reluctant to take part in cross-country health technology assessments (HTAs) offered by groups such as the recently revamped Joint Nordic HTA-Bodies (JNHB). Nevertheless, these initiatives are here to stay and companies should embrace the opportunities they offer, experts at the JNHB told the Pink Sheet in an interview... Global Sub. Full

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