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29, Medicare released its highly anticipated list of 10 therapies for which it plans to establish a price by 2026. Analysts have rightly criticized the congressional decision to once again confer greater protection on biologics.
Department of Health and Human Services named 10 medicines that will be subject to price negotiations for the Medicare program in 2026, a milestone and a point to start appraising the impact of the law , STAT explains. Amgen and J&J reached an agreement in May to allow a biosimilar for Stelara no later than Jan.
To support future growth of its biosimilar pipeline, Sandoz is planning to build a Biosimilar Technical Development Center in Slovenia. The company intends to invest approximately $90 million at its site in Ljubljana, Slovenia, to establish a dedicated Sandoz Biopharma Development Center by 2026.
The agreement covers the development and manufacture of multiple biosimilar medicines with an option for expansion. Development of the biosimilars will ramp-up over the coming 12-18 months.” The post Sandoz partners with Just–Evotec Biologics to develop and manufacture multiple biosimilars appeared first on Express Pharma.
The first stage of construction has officially begun on Lek Pharmaceuticals’ new biologics and biosimilars production centre in Lendava, north eastern Slovenia. The new biosimilars production centre will also include facilities for manufacturing and storage. The site employs 775 people full time, Sandoz said.
A drugmaker in China has developed a biosimilar version of Novo Nordisk’s popular diabetes drug Ozempic and applied for approval to sell it there, in a potential challenge to Novo expansion plans in the country , Reuters writes. Continue to STAT+ to read the full story…
As Medicare prepares to negotiate prices for its first batch of medicines, an advocacy group argues the agency should factor in controversial patent maneuvers for one drug that will have cost the program nearly $2 billion in additional spending by 2026 , STAT writes. At
(“THDB”) to market three insulin biosimilars (insulin aspart, insulin lispro, and insulin glargine) in the United States. NKF”), exclusive rights to commercialize the three biosimilar insulin products upon approval by the FDA, estimated to be on or around 2026. THDB and NKF will jointly handle product development and supply.
The global obesity market faces supply issues, prompting Chinese pharma companies to leverage the situation to develop GLP-1 biosimilars. In July 2023, China approved Huadong Medicine’s biosimilar of Novo Nordisk’s once-daily subcutaneous GLP-1 agonist injection liraglutide for obesity; a few more liraglutide biosimilars are in the pipeline.
Going forward, the company will continue to focus on developing generic and biosimilar medicines for the European medicines market, with focus on sustainable access. This would position the Ljubljana site as key location for its biosimilar product development, the company stated. This is about 25 percent of the total cost.
The European Commission (EC) has granted Sandoz the first marketing authorisation of biosimilar Tyruko ®* (natalizumab). Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019. The site is planned to be completed by 2026.
Fresenius Kabi and Formycon signed an international commercialisation deal in February last year for the ustekinumab biosimilar candidate for various markets across the globe. Otulfi is said to be the fourth biosimilar of is Fresenius Kabi to receive marketing authorisation in the US.
A Better Reform: Ensuring Savings Are Passed Onto Patients While price-setting proponents say beneficiaries will start to see lower drug prices beginning in 2026, there’s no evidence that this is true, and there are better ways to lower out-of-pocket costs- and much faster, Reilly explains.
Insulin Biosimilars: Meitheal Pharmaceuticals, Inc. to commercialize Tonghua Dongbao’s three insulin biosimilars (insulin aspart, insulin lispro, and insulin glargine) in the U.S. Meitheal and Tonghua Dongbao will be jointly responsible for development and supply, with the expectation of achieving FDA approval in 2026.
The €150 million facility in Kundl, Austria will produce the antibiotic penicillin, while the new €25 million facility in Holzkirchen, Germany will be Sandoz’s new Biosimilar Development Center. Launch of these new facilities help to ensure sustainable access to quality antibiotics and spearhead development of biosimilars, Sandoz noted.
Following these, the US market anticipates the 2026 introduction of additional URAT1 inhibitors – ABP-671 and SAP-001 – along with tigulixostat, a xanthine dehydrogenase inhibitor, and a topical sodium bicarbonate therapy.” Canakinumb, set for a 2030 launch, is a biosimilar to the established Ilaris therapy.
On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab). WEZLANA is the first product to be approved as a biosimilar to STELARA. In that case, according to CMS’s guidance, STELARA would cease to be “selected” on January 1, 2027.
On July 20, 2023, Sandoz announced that it plans to invest approximately $90 million to build a Biosimilar Technical Development Center in Ljubljana, Slovenia by 2026. The post Sandoz Invests in New Biosimilar Manufacturing Facility appeared first on Big Molecule Watch.
Hyman, Phelps & McNamara, P.C. (HP&M), HP&M), the largest dedicated food and drug law firm in the U.S., is pleased to announce that Director Allyson Mullen has been appointed to the Board of Directors of the Association of Medical Diagnostic Manufacturers (AMDM). This prestigious appointment recognizes Ms.
Sandoz, a division of Novartis , has signed a Memorandum of Understanding (MoU) for constructing a new biologics production plant in Lendava, Slovenia, to support the growing demand for biosimilar medicines worldwide. At Sandoz, we are determined to continue leading the way in driving access to these critical medicines.
Formulary Inclusion and Placement of Generics and Biosimilars The NHC supports CMS proposals to improve formulary practices by prioritizing access to generics, biosimilars, and other cost-effective medications in the Medicare Part D program.
AstraZeneca also claimed that CMS’s revised guidance on the Negotiation Program for Price Applicability Year 2026 (“Guidance”) interpreted the IRA in two very faulty ways, which violated the Administrative Procedure Act (APA) and harmed and will continue to harm the company. The court found numerous flaws with this argument.
As 2025 begins, we would like to reflect on last years regulatory developments in the biologics and biosimilars space. There were also 18 FDA approvals of biosimilar products , including 6 ustekinumab biosimilars and 5 aflibercept biosimilars in 2024 alone. These new prices will take effect starting January 1, 2026.
With the IRA, Congress changed the pricing model for certain “high-priced” Medicare-covered drugs without generic or biosimilar competition. The MFP will then be published on September 1, 2024, and will take effect on January 1, 2026. The process for the Drug Price Negotiation Program is as follows: Drug Selection.
Regarding CDER’s ETP, the current ETP guidance document, originally published in 2017, will be updated by the end of 2026, and will include details on communicating the type of products and stages of development for which a requestor can approach the ETP.
California pharmacists are still able to provide the oral therapeutics without requiring you to visit your primary care physician through January 1, 2026. The most common drug Californians may be looking for this winter is Paxlovid.
Without that effect the underlying growth was 5%, with rising use of biosimilars offsetting increased use of branded medicines, although IQVIA notes that the pharma sector has demonstrated “resilience and flexibility” in staging such a rapid recovery in the last two years.
September 1, 2023 will be the selection date for the 10 drugs that will be subject to “maximum fair price” ceilings under Medicare Part D starting in 2026. Chamber of Commerce makes all the arguments that the other plaintiffs have made, and also alleges that Congress has no power to levy the excise tax because it “compels” commerce.
On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The Discount Program is similar to the CGDP with respect to several requirements and operational processes, and CMS will implement it in a similar manner.
One of the major changes is the extension of the transition period from one to two years, with FDA now planning to enforce the QMSR requirements upon the effective date of the final rule on February 2, 2026.
In FY 2026 – FY 2027, continue to support products enrolled in previous fiscal years and expand to enroll up to 100 additional products each fiscal year within existing OHTs or expand to additional OHTs, depending on lessons learned from FY 2023 – FY 2025 experience (i.e., up to 125 total products enrolled through FY 2025).
While insulin price caps will begin this year, larger effects will be delayed until 2026 – when the US federal government will be allowed to negotiate Medicare prices and demand rebates from drug companies that price gouge. That leaves three years for pharma companies to prepare.
Priority is given to Suitability Petitions that could mitigate or resolve a drug shortage; address a public health emergency declared by HHS; mitigate waste by way of new strengths for parenteral products; or subject to special review under the President’s Emergency Plan for Aids Relief.
Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026.
With the current lapse in authorization, FDA may only award RPD PRVs for applications that have received an RPD designation before December 20, 2024, andunless reauthorized before thenmay not award any RPD PRVs after September 30, 2026. Below, we discuss some of its downstream impacts on the PRV landscape.
Note that Astellas withdrew its lawsuit after none of its drugs were selected for price reduction in 2026—potentially because that fact cut against its argument for standing. Harm The Court reviewed the parties’ arguments on “irreparable harm to Plaintiffs.”
COVID vaccines and treatments have created a substantial market over and above the existing Rx market- IQVIA estimates that the cumulative value of COVID vaccines could be between $185 and 295bn to 2026. Sarah holds a degree in biochemistry from Oxford University.
Labeling We note that while labeling requirements are not being phased in until stage 2 (May 6, 2026), the regulatory requirements in stage 1 appear to assume that at least some labeling requirements – such as UDI, which must be included in complaint files – will already be implemented).
Below is a recap of the top M&A deals in 2023 that focus on biologics and biosimilars and were covered on the Big Molecule Watch. Reddy’s”) to license Dr. Reddy’s proposed biosimilar abatacept for the development and commercialization of COYA 302 for the treatment of neurodegenerative conditions. Reddy’s Laboratories Ltd. (“Dr.
Adalimumab biosimilars are reshaping the landscape, impacting Humira and competitors like Janssen’s Stelara and Takeda’s Entyvio. However, as with Humira, revenues from these therapies are expected to decline with the release of their corresponding biosimilars, which are anticipated to enter the market in the coming years.
The “state-of-the-art” site will enable Sandoz “to meet growing demand for our current and future biosimilars in the mid- to long-term,” noted Glenn Gerecke, Global Head of Sandoz Technical Operations. The new plant will support the growing biosimilars sector. Full operations is provisionally planned for late 2026.
Though the entry of biosimilars will contract the market, significant growth is expected over the next 8-10 years, driven by the launch of new assets. The anticipated launches in the US and Europe of Janssen’s Tremfya (guselkumab) and Lilly’s mirikizumab, in Q4 2025 and Q3 2026, respectively, are expected to shape the market.
Type 2 diabetes (T2D) is a crowded and competitive landscape with multiple “me-too,” generic and biosimilar drugs entering the market, with market growth primarily driven by an increasing prevalent population across nine major markets (9MM: US, France, Germany, Italy, Spain, UK, Japan, China, and India).
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