Search Results for: Humira Biosimilar

Boehringer Ingelheim Adopts Dual-Pricing Strategy with Launch of Unbranded Humira Biosimilar

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Boehringer Ingelheim Adopts Dual-Pricing Strategy with Launch of Unbranded Humira Biosimilar

Boehringer Ingelheim, the company that recently introduced the first interchangeable biosimilar to AbbVie’s blockbuster drug Humira, is now embracing a dual-pricing strategy within the industry. Following the launch of its branded Humira biosimilar, Cyltezo, in July, Boehringer has unveiled an unbranded version of the inflammatory disease medication, simply named adalimumab-adbm injection. This unbranded biosimilar will … Read more

Biocon Biologics’ CEO reveals pricing strategy and device design for Hulio, its Humira biosimilar, in the US market

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Biocon Biologics Hulio launch, Hulio biosimilar Humira US, Biocon Biologics pricing strategy, Hulio patient-friendly device, Hulio market share US, Biocon Biologics Viatris acquisition, Hulio biosimilar approval FDA,

The competition in the biosimilar arena targeting AbbVie’s blockbuster drug Humira, also known as adalimumab, is heating up. However, for Biocon Biologics CEO Shreehas Tambe, the battle is not solely about gaining market share but also about recognizing the substantial value even a small market share can yield. Before entering the Humira biosimilar market in … Read more

Alvotech Seeks Interchangeability Status for Humira Biosimilar Again

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Humira Biosimilar, Alvotech, Interchangeable biosimilar, AVT02, Humira

Alvotech is forging an audacious path towards a potential game-changer. CEO Robert Wessman recently unveiled a resubmission of their Biologics License Application to the FDA, a strategic move aimed at securing an “interchangeability” designation for AVT02. This high-concentration biosimilar is Alvotech’s response to AbbVie’s formidable Humira (adalimumab). This announcement, while sparking intrigue, leaves us in … Read more

Humira Biosimilars: Benefits, Availability, Price, Comparison and More

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Humira Biosimilars: Benefits, Availability, Price, Comparison, and More

In this article, we will give you an overview of Humira biosimilars, including their benefits, availability, prices, and how they compare to Humira. We will also answer some frequently asked questions about Humira biosimilars and provide some tips on how to switch from Humira to a biosimilar safely and smoothly. Humira is a brand-name medication … Read more

Samsung wants to describe its Humira biosimilar as “interchangeable.”

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Samsung Seeks Interchangeable Status for Humira Biosimilar

While several biosimilars of AbbVie’s top-selling drug, Humira, are already available in the US market, only one, Boehringer Ingelheim’s Cyltezo, has achieved the coveted interchangeable status. This designation allows Cyltezo to be switched for the original Humira without the need for prescriber intervention. Samsung Bioepis and its marketing partner, Organon, now have the clinical data … Read more

Humira biosimilar to be made available by RxPreferred via Mark Cuban’s online pharmacy

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Humira biosimilar to be made available by RxPreferred via Mark Cuban's online pharmacy

Pharmacy benefits manager (PBM) RxPreferred has unveiled its plan to provide the Humira biosimilar Yusimry through Mark Cuban Cost Plus Drugs, an online pharmacy launched by celebrity investor Mark Cuban in 2022. Commencing in July 2023, RxPreferred aims to offer Yusimry to its members for a price of $569.27, in addition to dispensing and shipping … Read more

Teva and Alvotech face FDA rejection for Stelara biosimilar after Humira setbacks

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Alvotech, Stelara, Johnson & Johnson, Humira, Teva Pharmaceuticals, Reykjavik

Ongoing issues at the Alvotech manufacturing facility in Reykjavik have led to yet another FDA rejection, this time affecting the proposed biosimilar of Johnson & Johnson’s popular drug Stelara, which was developed in collaboration with Teva Pharmaceuticals. The FDA’s action on Alvotech’s AVT04 biosimilar cited “certain deficiencies” uncovered during a facility reinspection in March. These … Read more

Humira sales decline as biosimilars gain traction, but physicians remain wary of switching patients

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humira, biosimilars, sales, switching, spherix, physicians, market share

In the race to capture a share of the $20 billion annual revenue generated by AbbVie’s blockbuster biologic, Humira biosimilars have made their presence known this year. However, according to an analysis by Spherix Global Insights, these biosimilars have yet to make a substantial impact on the market. The analysis highlights a “continued erosion” of … Read more

Amgen Secures FDA Approval for Stelara Biosimilar, Awaits 2025 Launch Post-Settlement

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Amgen Wins FDA Approval for Stelara Biosimilar

The FDA has granted approval to Amgen for its biosimilar rendition of Johnson & Johnson’s renowned autoimmune medication, Stelara. However, Amgen’s new product won’t be hitting the market anytime soon. In May, as part of an agreement between the two pharmaceutical giants, Amgen consented to postpone the launch of its Stelara biosimilar in exchange for … Read more

FDA Approves 5-Minute Tests for Monitoring Humira and Remicade Doses in Inflammatory Bowel Disease Patients

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FDA Approves 5-Minute Tests for Monitoring Humira and Remicade Doses in Inflammatory Bowel Disease Patients

The FDA has recently granted two de novo clearances to ProciseDx, marking a significant advancement in personalized medicine for patients with inflammatory bowel diseases (IBD). These clearances pave the way for the first rapid tests that can swiftly measure specific biologic drug levels in a patient’s bloodstream, enabling clinicians to conduct on-site monitoring and tailor … Read more

Regeneron Faces New Challenges as Biosimilars Target Eylea Market Dominance, Novartis’ Sandoz Takes Aim with Therapeutic Equivalence

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How Sandoz Challenges Regeneron’s Eylea with its Biosimilar in a Phase III Trial

Regeneron finds itself at a crossroads as its blockbuster eye drug Eylea contends with an FDA rejection and growing competition from biosimilar contenders. Novartis subsidiary Sandoz recently announced promising results from a Phase III trial, indicating that its Eylea biosimilar exhibited no clinically meaningful distinctions from the originator drug in patients with wet macular degeneration. … Read more

AbbVie Raises Profit Expectations Despite Q2 Decrease in Humira and Imbruvica Sales

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AbbVie Beats Profit Forecast Despite Humira, Imbruvica Drop

AbbVie executives express satisfaction with the introduction of Humira biosimilars in the US, despite facing significant revenue declines for both Humira and another key drug in their portfolio. The company now expects Humira’s sales erosion to reach 35% this year, a slight improvement from the previous estimate of 37%. To offset the impact of growing … Read more

Teva Expands Alvotech Collaboration with 2 New Biosimilar, $40M Investment & Enhanced Oversight

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Teva and Alvotech Boost Biosimilars Deal with New Products and Investment

Source – Teva Pharmaceuticals Following the second FDA rejection of Teva’s Alvotech-partnered biosimilar for Humira, the two companies are expanding their collaboration and making strategic moves to strengthen their long-term partnership. Teva, a major generics giant, is taking on a more active role in the collaboration by increasing its involvement in manufacturing and providing financial … Read more

AbbVie claims that Coherus violated the Humira patent settlement by working with Mark Cuban’s pharmaceutical company

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AbbVie claims that Coherus violated the Humira patent settlement by working with Mark Cuban's pharmaceutical company

AbbVie says that Coherus breached a licensing agreement that controls the commercialization of the biosimilar in a regulatory filing. The spat started two weeks ago when Mark Cuban Cost Plus Drug Co. said it would charge $569.27 for a carton of two autoinjectors of the Coherus biosimilar, which would be marketed as Yusimry and go … Read more

Samsung Biologics Secures $411 Million Long-Term Deal with Pfizer for Biosimilar Production

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Samsung Biologics Secures $411 Million Long-Term Deal with Pfizer for Biosimilar Production

South Korea’s Samsung Biologics has recently entered into another significant manufacturing agreement, this time with Pfizer, worth $411 million. The deal involves Samsung providing additional large-scale manufacturing capacity for a diverse portfolio of biosimilars, spanning oncology, inflammation, and immunology. The partnership between the two companies is described as a long-term arrangement. Pfizer’s biosimilar portfolio includes … Read more

Sandoz Aims for Success in Biosimilars, Forecasts $3 Billion in Sales from Pipeline Products in Next 5 Years

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Sandoz Aims for Success in Biosimilars, Forecasts $3 Billion in Sales from Pipeline Products in Next 5 Years

Sandoz, the generics and biosimilars division of Novartis, is set to become an independent company and is determined to reverse its declining revenue trend since 2016. The company anticipates that its pipeline products, particularly biosimilars, will contribute $3 billion in sales over the next five years. In an investor presentation held in New York City, … Read more

Amgen challenges FTC’s bid to block $28B Horizon deal

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Amgen, Horizon Therapeutics, Federal Trade Commission, M&A

Amid the ongoing legal battle with the Federal Trade Commission (FTC) over its $28 billion acquisition of Horizon Therapeutics, Amgen has responded with strong assertions in court documents. In response to the FTC’s request for a preliminary injunction, Amgen’s legal team has stated that the FTC’s case is detached from reality and lacks grounding in … Read more

Boehringer Ingelheim Soars with Jardiance Growth as US Kidney Disease Approval Looms

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How Jardiance Lifts Boehringer Ingelheim’s Revenue as US Decision Looms

Source – Boehringer Ingelheim Boehringer Ingelheim is gearing up for the launch of Jardiance, a diabetes and heart failure drug, in chronic kidney disease (CKD), and it has had a strong start to 2023 with impressive pharmaceutical sales growth. During the first half of 2023, the German drugmaker reported a significant 9.7% increase in overall … Read more

MoonLake’s IL-17 Drug Gains Momentum with New Phase 2 Success

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MoonLake's IL-17 Drug Gains Momentum with New Phase 2 Success

MoonLake Immunotherapeutics has achieved promising results in a phase 2 trial for its IL-17 inhibitor, sonelokimab, aimed at treating inflammatory skin conditions, particularly psoriatic arthritis. The trivalent camelid nanobody showed a statistically significant response in patients with active psoriatic arthritis, with 46% and 47% of those receiving the 60-mg and 120-mg doses, respectively, experiencing a … Read more

AbbVie writes off $2.1B for Imbruvica amid CMS pricing pressure

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AbbVie writes off $2.1B for Imbruvica amid CMS pricing pressure

The introduction of BeiGene’s groundbreaking oral treatment, Brukinsa, has taken a toll on the sales of AbbVie and Johnson & Johnson’s leukemia drug, Imbruvica. However, another factor poised to impact Imbruvica’s future is the Inflation Reduction Act. In August, the Centers for Medicare & Medicaid Services (CMS) identified Imbruvica as one of 10 drugs subject … Read more

Amgen Successfully Completes $27.8B Acquisition of Horizon After FTC Dispute Resolution

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Amgen Successfully Completes $27.8B Acquisition of Horizon After FTC Dispute Resolution

Amgen has successfully concluded its monumental $27.8 billion acquisition of Horizon Therapeutics, triumphing over a legal challenge posed by the US antitrust watchdog. The announcement of this significant milestone came from the California-based pharmaceutical giant on a momentous Friday, following the formal approval from the High Court of Ireland the day prior. Originally unveiled in … Read more

AbbVie’s Skyrizi beats J&J’s Stelara in Crohn’s disease showdown

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AbbVie, Skyrizi, Stelara , Johnson & Johnson, Crohn’s disease

AbbVie’s revolutionary anti-inflammatory medication, Skyrizi, has been consistently outperforming its competitors in recent clinical trials, making waves in the field of inflammatory diseases. In its latest triumph, Skyrizi has gone head-to-head with Johnson & Johnson’s Stelara in a successful study focusing on Crohn’s disease treatment. The results are nothing short of impressive: Skyrizi not only … Read more

FDA Approves Novartis’ Tyruko: Revolutionizing MS Treatment Landscape Amidst Legal Drama

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Novartis, Biogen, Biosimilar, Tysabri, FDA Approval, Sandoz, Tyruko

Stepping onto the stage with a flourish, Novartis has secured a resounding victory against Biogen in the realm of pharmaceutical innovation. Just a mere sixty days following the dismissal of Biogen’s patent infringement case by a Delaware federal court, Novartis emerges triumphantly, poised to introduce its biosimilar alternative for the widely used multiple sclerosis (MS) … Read more

AbbVie’s Epcoritamab (EPKINLY) Receives Positive CHMP Opinion for DLBCL Treatment

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AbbVie’s Epcoritamab Gets CHMP Nod for DLBCL

Source – AbbVieAbbVie and Genmab’s potential blockbuster drug epcoritamab has received a favorable recommendation for conditional approval in the EU as a treatment for diffuse large B-cell lymphoma (DLBCL), a highly aggressive form of non-Hodgkin’s lymphoma. The European Medicines Agency’s human medicines committee (CHMP) has issued a positive opinion on epcoritamab, a CD20xCD3 bispecific antibody, … Read more

Sandoz Enters US Immunology Market with Launch of High-Concentration Formulation Hyrimoz

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Sandoz Enters US Immunology Market with Launch of High-Concentration Formulation Hyrimoz

Source – Novartis On July 1, 2023, Sandoz made an announcement regarding the availability of their biosimilar Hyrimoz (adalimumab-adaz) injection in the United States. They introduced the citrate-free high-concentration formulation (HCF) of Hyrimoz, which will be accessible from that date onwards. Hyrimoz HCF, with a concentration of 100 mg/mL, has received approval for the treatment … Read more

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