Monday, November 11, 2024

GRx+Biosims Market Leaders Lessons for Biosimilars

(11/8, Craig Burton, Biosimilars Council) ...Mary Pietryga of Teva Pharmaceuticals emphasized that education isn't just important—it's imperative. There's a gap in awareness among both patients and providers that holds back adoption. Addressing this gap could accelerate the realization of cost savings and accessibility that biosimilars promise. Mary also spoke to the impact of current market dynamics, including how pharmacy benefit managers often favor brand biologics, creating challenges for lower-priced biosimilars. A more competitive PBM landscape could make all the difference... Full

Opinion: Drugs Are Becoming ‘Smarter.' Here's How

(11/11, David Benshoof Klein, BioSpace) ...Partnerships to develop software-enhanced drug therapies are already underway. Teva UK, working with tech-bio company Closed Loop Medicine, has invested in the development of personalized medicines, which will combine software as a medical device with Teva's existing pipeline of drugs. Remepy is a new company that plans on developing combination products that combine traditional drugs with its digital treatments in therapeutic areas such as mild cognitive impairment and Parkinson's disease... Full

Meitheal Brings In Another Three US Biosimilars

(11/8, Dave Wallace, Generics Bulletin) ...Meitheal Pharmaceuticals has announced that it is adding another three biosimilars to its pipeline for the US market, with an exclusive commercial licensing agreement with its parent company Hong Kong King-Friend Industry adding filgrastim, pegfilgrastim and follitropin alfa to its existing roster of five products... Global Sub. Full

Organon's Q3 Results Meet Analyst Expectations

(11/8, Adam Zamecnik, Generics Bulletin) ...The US-headquartered firm's revenue for the third quarter of 2024 rose to $1.58bn, which marks a 4% increase as-reported and a 5% spike at constant currency. Alongside this, the firm reported a net income of $359m for the period, with an adjusted EBITDA (non-GAAP) of $459m. Nevertheless, some industry analysts have pointed out slight slumps in the performance of the company's biosimilars and women's health segments... Global Sub. Full

Biocon Share Jumps 6% On USFDA's 'VAI' Tag to Bengaluru Facility; Details

(11/11, Business Standard) ...This is related to the combined current good manufacturing practices (cGMP) inspection and Pre-Licensing Inspection conducted by the USFDA between July 15 – 26, 2024... Full

Aurobindo Pharma Q2 Net Profit Rises 8.6% to Rs 817 Crore in Q2FY25

(11/10, Viswanath Pilla, The Economic Times) ...Aurobindo Pharma on Saturday reported 8.6% year-on-year (YoY) rise in net profit to Rs 817 crore in the second quarter ended September 2023, led by strong sales from the Europe and growth markets..."While profitability saw a slight dip, primarily due to the transient nature of certain business activities, our underlying performance remains strong," said K. Nithyananda Reddy, vice-chairman and managing director... Full

Stada Said to Pick IPO Bookrunners, Eye Kickoff Early Next Year

(11/8, Swetha Gopinath and Eyk Henning, Bloomberg) ...Barclays Plc, Citigroup Inc. and HSBC Holdings Plc have been added to help with arranging the potential share sale in Germany, said the people, who asked not to be identified as the information is private. Jefferies Financial Group Inc. and UBS Group AG are also part of the bookrunner lineup, the people said. Stada could be valued at €10 billion ($11 billion) or more in a listing, the people said... Full

Baxter Warns Hurricane Disruptions at IV Facility May Hit Financials in 2025

(11/8, Christy Santhosh, Mariam Sunny, Reuters) ...While all manufacturing lines at the facility are expected to resume before the end of this year, the production of a key IV product will reach full capacity only in early 2025, CEO José Almeida said in an earnings call. This could marginally impact first-quarter 2025 financials as the 1-liter IV bags constitute almost half of the IV production at the North Carolina facility, Almeida said... Full

Alembic Pharma Gets US FDA Nod for Diltiazem Hydrochloride ER Capsules

(11/11, Business Standard) ...Alembic Pharmaceuticals said that it has received final approval from the US Food & Drug Administration for its abbreviated new drug application for Diltiazem Hydrochloride extended-release capsules. The approved ANDA is therapeutically equivalent to the reference listed drug product, Cardizem CD extended-release capsules of Bausch Health US, LLC. The approved strengths for the said drug are 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg... Full

Lupin Receives Tentative U.S. FDA Approval for Raltegravir Tablets

(11/11, Express Pharma) ...Lupin, a global pharmaceutical company, has announced its tentative approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Raltegravir Tablets USP, 600 mg. The approval enables Lupin to market a generic equivalent of Isentress HD Tablets, 600 mg, produced by Merck Sharp & Dohme LLC... Full

Alteogen and Daiichi Sankyo Sign License Deal for ADC Development

(11/11, Pharmaceutical Business Review) ...Alteogen has entered into an exclusive license agreement with Daiichi Sankyo for the development and commercialisation of a subcutaneous version of ENHERTU (fam-trastuzumab deruxtecan-nxki), an antibody drug conjugate (ADC). ALT-B4 will be used for developing the subcutaneous formulation ENHERTU... Full

Baltimore Jury to Decide if Drug Companies Are Responsible for City's Opioid Crisis

(11/8, Christian Olaniran, Dennis Valera, CBS News) ...The city has already secured $400 million in settlements from other opioid companies, including Walgreens, Johnson & Johnson, Teva Pharmaceuticals, and CVS in similar lawsuits. Jurors will now determine if the two companies, McKesson and AmerisourceBergen, were a "public nuisance" to Baltimore... Full

GSK Calls it Quits On Trade Group BIO for 2025, Following Exits by Takeda, UCB and More

(11/8, Zoey Becker, Fierce Pharma) ...The British drugmaker has opted not to renew its BIO membership for 2025 following an annual evaluation of its corporate memberships and trade association participation, a spokesperson said in an emailed statement. "We remain committed to fostering a policy environment that prioritizes disease prevention, addresses health equity and access barriers, and incentivizes sustainable innovation," the company representative added. "At this time, we believe there are other areas we can focus our resources."... Full

RSV Vaccines: ACIP Recommendations For Adults Younger Than Age 60 Await More Data

(11/8, Sue Sutter, Pink Sheet) ...GSK's Arexvy and Pfizer's Abrysvo are FDA-approved for individuals younger than 60 years old, but CDC's Advisory Committee on Immunization Practices wants more data on Guillain-Barré syndrome cases in older adults and efficacy in severely immune-compromised persons before making a recommendation... Global Sub. Full

Challenges, Obstacles, and Future Directions for Anti-TNF Biosimilars in IBD

(11/9, Deana Ferreri, PhD, The Center For Biosimilars) ...A review article on tumor necrosis factor (TNF)-a inhibitors in inflammatory bowel disease outlined current use of anti-TNF originators and biosimilars, their efficacy and safety, the benefits and challenges of biosimilars, and the future of biosimilars in IBD... Full

Study Documents Detrimental Effects of Drug Shortages, in This Case Etoposide

(11/8, Vinay Gupta, MD, MedPage Today) ...A study in JCO Oncology Practice retrospectively reviewed outcomes during a period of sustained etoposide shortage in Canada lasting over 2 years from 2018 until 2020. While there are alternate regimens available for use, these are not in common practice and oncologists prefer to use intravenous etoposide as the platinum partner. The results of this study show a negative patient outcome during this period of etoposide shortage, in terms of progression-free survival as well as an increased rate of hospitalization... Full

How Strategic IDNs Boost Biosimilar Adoption

(11/10, Skylar Jeremias, The Center For Biosimilars) ...Sophia Humphreys, PharmD, MHA, BCBBS, director of system formulary management at Sutter Health, discusses how integrated delivery networks (IDNs) can help drive biosimilar adoption... Full

If Cassidy's At HELP Helm, Approach To GLP-1 Pricing May Change

(11/8, Luke Zarzecki, InsideHealthPolicy) ...After Senate Republicans won a majority in the chamber Tuesday (Nov. 5), the Senate health committee could change its tune on the pricing of obesity drugs and put less pressure on Novo Nordisk's pricing of its GLP-1 products and more emphasis on innovation... Sub. Req’d

Medicaid Spending On GLP-1s More Than Doubled From 2022 To 2023

(11/8, Luke Zarzecki, InsideHealthPolicy) ...Medicaid spending on GLP-1 drugs more than doubled between 2022 and 2023, according to a new KFF analysis published Monday (Nov. 4), which also says cost is the top reason for states deciding not to cover the medications...Between 2022 and 2023, spending on GLP-1s climbed from $1.9 billion to $3.9 billion. "Specifically, increased utilization of Ozempic, Wegovy, and Mounjaro have contributed substantially to recent growth," the report says... Sub. Req’d

Counterfeit Weight Loss Drugs Sold Online, Feeding Demand for Cheaper Options

(11/8, Tom Hanson, Aparna Zalani, Justin Sherman, Ryan Beard, CBS News) ...The Food and Drug Administration has issued warnings to multiple online pharmacies selling suspected counterfeit products...Despite their efforts, a quick internet search by CBS News in September 2024 found these websites remain active or redirect users to other sites offering these questionable drugs...Novo Nordisk, the maker of Ozempic, Rybelsus and Wegovy, said in a statement to CBS News: "It's important that patients are aware that Novo Nordisk is the only company in the U.S. with FDA-approved medicines containing the main ingredient semaglutide. FDA has not approved any generic versions of semaglutide."... Full

Rebate Game Played By PBMs And Drug Makers Limits Biosimilar Competition

(11/10, Joshua P. Cohen, Forbes) ...Beginning in 2023, five years after their European counterparts, patients in the United States prescribed the autoimmune disease treatment Humira could finally choose from lower-priced biosimilars. However, the rebate game played by drug manufacturers and pharmacy benefit managers in the U.S. limits optimal biosimilar competition. As a result, U.S. patient out-of-pocket costs are too high... Full

Shedding Light On Payers And PBMs As Possible Drivers Of Opioid Crisis

(11/8, Joshua P. Cohen, Forbes) ...A recent Barron's exposé details the role of PBMs in possibly fueling the opioid crisis. PBMs are important intermediaries in the prescription drug ecosystem, wielding power over which medications patients have access to and how much they cost. What the Barron's article doesn't emphasize is that PBMs serve at the behest of payers, which include employers, health plans and government agencies. On behalf of payers, PBMs negotiate net prices for drugs in conjunction with determining their positioning on formularies, or lists of covered medicines... Full

What The Trump Administration Could Mean for the Health Care Industry, From Hospitals to Pharma

(11/11, Rachel Cohrs Zhang, Bob Herman, and Tara Bannow, STAT Plus) ...If Republicans maintain control of the House, it opens the possibility that Republicans could revisit parts of the law that have garnered the most disdain from the pharmaceutical industry, like unequal monopoly periods for different types of drugs, limits to incentives for drugs designated to treat rare diseases, and short-term protections for small biotech companies. Some bipartisan legislation has already been introduced... Sub. Req’d

2025 Part D Landscape Files Reveal Plans Are ‘Managing Their Risk More Carefully'

(11/8, Leslie Small, Pink Sheet) ...PDP premium increases were not as steep as some expected, but evidence still suggests they still are working to reduce the risk of policy changes. Basic and enhanced plan premiums are moving in different directions. Plans are not letting some regions subsidize others and managing risk more carefully... Global Sub. Full

Prescription Drugs in the US Must Be Viewed as Critical Infrastructure | ASPL 2024

(11/9, Brian Nowosielski, Drug Topics) ...In order to ensure the safety and integrity of the US drug supply chain, it's important for all parties acting within it to consider the drugs themselves as critical infrastructure to the country as a whole, not just within the pharmaceutical industry. With so much of the active pharmaceutical ingredients (APIs) of drugs being imported from other countries like India and China, drug shortages have become an increasingly significant issue that threatens the fabric of critical infrastructure within the US... Full

USP: India and China Continue Their API Manufacturing Reign

(11/8, Joanne S. Eglovitch, Regulatory Focus) ...According to the US Pharmacopeia's Medicine Supply Map, only 4% of the active API DMFs filed with FDA in 2023 cited US manufacturing facilities; 50% were held by India, followed by China at 32%, the EU at 10% and other countries at 4%. DMFs are submitted to FDA by companies supplying drug ingredients to another company and are confidential and stripped of proprietary information. USP notes that not all drug products are made with APIs referencing DMFs, and that the proportion of DMFs is not necessarily indicative of total output by a country or region... Full

FDA Records Request Lands Chinese API Manufacturer On Blocked Import List

(11/8, Zachary Brennan, Endpoints News) ...The FDA this week posted an untitled letter sent Oct. 17 to China-based active pharmaceutical ingredient (API) manufacturer Shandong Boyuan Pharmaceutical Co., whose exports to the US have been blocked by the regulator. The agency said in the letter that the API manufacturer, which on its website says it works with Indian generic drugmakers like Dr. Reddy's and Cipla, will remain on the US government's list of blocked imports until the manufacturing facility can verify that it's compliant with current good manufacturing practices... Full

GRx+Biosims 2024 Conference Recap

(11/8, Jennifer Soup, AAM) ...The conference kicked off with opening remarks from AAM's Executive Vice President, David Gaugh, and the association's new President and CEO, John Murphy III. John highlighted the significant role of generics and biosimilars, noting, "Generic and Biosimilar Medicines represent 90% of prescriptions dispensed, but only 13% of total drug spending," setting the stage for discussions on improving access to affordable medications... Full

A Conversation With …: He's the F.D.A.'s Cancer Chief, Not a Fortune Teller

(11/8, Gina Kolata, The New York Times) ...Cancer death rates have been plunging, and researchers attribute most of that to improved treatments. Overseeing this change at the Food and Drug Administration has been Dr. Richard Pazdur, currently the director of the Oncology Center of Excellence. Trained as an oncologist, he leads the agency and its cancer specialists in determining how cancer drugs are tested and approved... Full

IGBA Kicks Off Global Biosimilars Week 2024

(11/11, Dave Wallace, Generics Bulletin) ...First launched back in November 2020, the annual campaign is now in its fifth year, with 2024's incarnation running from 11-14 November. A supporting website offers multiple resources on biosimilars, including a flyer summarizing the campaign and its goals, as well as featuring information on how to get involved. "The IGBA invites all stakeholders to join us in Global Biosimilars Week 2024 to discuss the importance and benefits of advancing patient access and availability of biosimilars and share their solutions for how to make this global priority a reality," said Susana Almeida, secretary general of the IGBA... Global Sub. Full

Canada Approves Moderna's RSV Vaccine for Adults Aged 60 and Older

(11/8, Bhanvi Satija, Reuters) ...Moderna said on Friday Canada's health regulator has approved its vaccine for respiratory syncytial virus in adults 60 years and older, making it the country's first authorised mRNA-based shot for the condition. Health Canada has approved the vaccine, mRESVIA, for prevention of lower respiratory tract disease in older adults, the company said, adding that its supply is expected in early 2025... Full

'Weight' & Watch: Indian Pharma Set To Enter Ozempic, Wegovy Market, But Swift Price Crash Unlikely

(11/9, Himani Chandna, News 18) ...Globally the demand for weight-loss drugs, specifically the glucagon-like peptide-1 (GLP-1) class of medications is "exploding", experts told News18. The drug is used to treat type 2 diabetes and obesity and it works by mimicking the effects of the body's natural hormone, GLP-1, which helps to reduce appetite, slow digestion, boost insulin production, and decrease the amount of sugar produced by the liver. Health experts eagerly anticipate the launch of these drugs in India to meet the rising demand... Full

Korea Should Foster Pharmaceutical and Bio Companies.

(11/11, Park Joonhyoung, Maeil Business Newspaper) ...Many people, as well as people in the pharmaceutical and bio industries, agree on this proposition. They say that the pharmaceutical and bio industries are essential for Korea to break away from traditional manufacturing industries such as semiconductors, automobiles, and shipbuilding to create new food. According to the Korea Bio Association, the global pharmaceutical market is expected to reach $2.238 trillion (about 3,132 trillion won) in 2028. If Korean companies say they should give up such a market, they will be treated as strange people... 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 Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

 

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.