Search Results for “biosimilar ” – Page 10 – media

AbbVie’s full year 2023 sees 6.4% net revenue drop

AbbVie has reported a decrease in net revenues to $54.32bn for the year ended 31 December 2023, marking a 6.4% decline from the previous year’s $58.05bn.The company’s diluted earnings per share (EPS) on a generally accepted accounting principles basis also fell sharply by 59% to $2.72, compared to $6.63 in 2022.Adjusted diluted EPS saw a 19.3% decrease from $13.77 to $11.11. The company’s global immunology portfolio, which faced stiff competition from Humira biosimilars, saw revenues decrease by 9.6% to $26.14bn.Humira’s global net revenues stood at $14.40bn while Skyrizi and Rinvoq contributed $7.76bn and $3.97bn respectively. In the oncology sector, AbbVie’s global net revenues experienced a 10.1% decrease, amounting to $5.92bn.Its neuroscience portfolio showed resilience with an 18.2% increase in global net revenues, reaching $7.72bn. The aesthetics portfolio, however, recorded a slight decrease of 0.8%, with revenues of $5.29bn.AbbVie has provided an adjusted diluted EPS guidance range for 2024 between $11.05 ...
- Source: drugdu
- 99
- February 10, 2024
FDA and EMA team up to expedite complex generic drug development

In a move to enhance patient access to complex generic drugs, the FDA’s Office of Generic Drugs (OGD) and the EMA have joined forces in a new pilot programme. This initiative, an extension of the original parallel scientific advice (PSA) programme, homes in on complex generics, also known as ‘hybrid medicines’ as per EMA terminology.Launched in 2005, the original programme offers a means for sponsors of new medicines to seek guidance from regulatory agencies in both the US and EU, regarding scientific matters related to product development. The new voluntary programme aims to facilitate concurrent discussions between generic drug manufacturers and regulatory bodies, with the ultimate goal of improving patient access to harder-to-develop generic drugs. To participate in the PSA programme, applicants must submit requests to the EMA and FDA. Examples of suitable candidates for this programme include proposals for single bioequivalence studies, approaches with common comparators, and the use ...
- Source: drugdu
- 116
- February 8, 2024
As Humira plummets, AbbVie dials up Rinvoq and Skyrizi estimates to a combined $27B

As AbbVie slogs through sharp revenue declines for Humira, the company is looking to the immunology light at the end of the tunnel. During the final quarter of 2023, sales of Humira—which once sat pretty as the world’s best-selling drug—plunged nearly 41% to $3.3 billion globally. The rate of erosion seems to have gathered steam in the fourth quarter and outpaced the med’s full-year sales decline of around 32%. Still, AbbVie and investors knew this blow was coming. The plan—following the entry of Humira biosimilars early last year—is to weather the brunt of the attack in 2024 before charting a return to growth in 2025 and beyond, Robert Michael, AbbVie’s chief operating officer, said on a call with investors Friday. Specifically, AbbVie will rely on its roster of growth products, including Humira’s immunology heirs Rinvoq and Skyrizi, to help “absorb the largest loss of exclusivity event to date across our ...
- Source: drugdu
- 81
- February 6, 2024
Successful publication of 5-year long-term follow-up results of Phase III randomized controlled study of CD20 monoclonal antibody Hanlikang® in patients with primary diffuse large B-cell lymphoma

Hanlikang® (rituximab injection), the first CD20 monoclonal antibody independently developed by Henlius and also the first biosimilar in China, was officially approved for listing and registration by the State Administration of Pharmaceutical Affairs (SDPA) on February 22, 2019, which fills the gaps of the domestically-produced CD20 monoclonal antibody and domestic biosimilar market, and enables more Chinese patients to benefit from it! Recently, the 5-year follow-up results of patients in the Phase III study of Hanlikon® were officially published in the journal BMC Cancer (HLX01-NHL03 open-label extension study, NCT04491721). The results of the phase III HLX01-NHL03 study have demonstrated the bioequivalence of HLX01 (Hanlikon®, a rituximab biosimilar) compared to rituximab (Merovia®) in untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL). Here, we report 5-year follow-up results from an open-label extension study. Patients were randomly assigned to receive rituximab (Merova®) + cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or HLX01 (Hanlikon®) + ...
- Source: drugdu
- 177
- January 30, 2024
//www.fiercepharma.com/pharma/johnson-johnson-settles-talc-consumer-protection-claims-42-states-700m

For more than 2 years, Johnson & Johnson has been plotting its future as a two-sector company. In the wake of the company’s consumer healthcare spinoff last summer, the company’s fourth-quarter results offer plenty of signs of life from the new-look J&J.After wrapping up 2023 with a total haul of $85.2 billion, the company is heading into 2024 with “multiple catalysts for growth,” CEO Joaquin Duato said on J&J’s fourth-quarter and full-year earnings conference call. Across J&J’s innovative medicines portfolio, the company’s oncology and immunology medicines generated the lion’s share of sales in 2023’s fourth quarter, helping the unit achieve operational growth in the U.S. of 9.5% during the period. Worldwide, J&J’s pharma business reeled in $13.72 billion during the fourth quarter, a 4% increase from the same period in 2022.On the immunology front, J&J’s antibody blockbuster Stelara grew its market share and demonstrated continued strength in inflammatory bowel disease (IBD), J&J said in ...
- Source: drugdu
- 84
- January 25, 2024
Bayer’s Cost-Cutting Plans Take Aim at Multiple Layers of Management

CEO Bill Anderson said despite prior cost-cutting measures, Bayer still has too many layers of management and bureaucracy. A new restructuring will come with layoffs but the corporate shakeup plan does not yet include a separation of Bayer’s business units. By FRANK VINLUAN Bayer is implementing a corporate restructuring that will slash an unspecified number of jobs, particularly within management. But the strategy does not include a breakup of the conglomerate—at least not yet. In announcing its new strategy late Wednesday, Bayer said it aims to reduce hierarchies and eliminate bureaucracy in the company. The job cuts will happen over the coming months and will be completed by the end of next year at the latest, the company said. Bayer’s corporate shakeup is not entirely a surprise. CEO Bill Anderson, who joined Bayer last June after serving as the chief executive of Roche’s pharmaceuticals division, has been critical of bloat ...
- Source: drugdu
- 118
- January 20, 2024
Results from Clinical Trials of Two Henlius’ Novel Products Released at ASCO GI 2024

Recently, the latest clinical data of two Henlius products were released online and will be presented in poster sessions at the 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI), namely, the phase 2/3 study (HLX10-015-CRC301) of Henlius’ NMPA approved anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) in metastatic colorectal cancer (mCRC) with Professor Rui-Hua Xu of Sun Yat-Sen University Cancer Center as the leading principal investigator, and the phase 2 study (HLX22-GC-201) of Henlius’ novel anti-HER2 mAb, HLX22, combined with HANQUYOU (trastuzumab for injection, HLX02, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®) and chemotherapy for the first-line treatment of HER2-positive gastric/gastroesophageal junction (G/GEJ) cancer with Professor Jin Li of Shanghai East Hospital, School of Medicine, Tongji University as the leading principal investigator of this study. Colorectal cancer (CRC) is one of the most common malignancies globally. Over 1.9 million newly diagnosed cases and more than 900,000 deaths ...
- Source: drugdu
- 181
- January 19, 2024
China is a Key Pillar for Novartis

Speaking to Sina Finance in Davos, NOVARTIS Global CEO Vas Narasimhan said he is optimistic about the global economy and the company’s next steps, which are characterized by enormous business opportunities despite many challenges. Vas said he was impressed by the continued upgrading and improvement of China’s healthcare system. China is NOVARTIS’ second-largest and fastest-growing market in the world. Overall, I feel very optimistic,” Wansheim said of his experience at Davos. One of the interesting things about Davos is that it brings together so many people who are passionate about improving the world, and so many new ideas in one place.” “As we know, we face many challenges, both in terms of the geopolitical situation and the global economy. But at the same time, I think there are also tremendous opportunities. We are gaining insights into how AI can impact many aspects of life and improve our productivity. At the ...
- Source: drugdu
- 187
- January 19, 2024
Pfizer PARP inhibitor Talzenna nabs EU combo nod

• Pfizer’s PARP inhibitor Talzenna has gained European approval when used in combination with Pfizer and Astellas’ Xtandi to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. This approval makes Talzenna the first PARP inhibitor in Europe to be licensed in combination with Xtandi in mCRPC, Pfizer said in a release. The European Commission approved Pfizer’s application based on data from the phase 3 TALAPRO-2 trial, which showed that the combo cut the risk of disease progression or death in patients with mCRPC compared with placebo and Xtandi. Last June, the FDA approved the combination to treat adults with HRR gene-mutated mCRPC. • In another regulatory win for Pfizer, the FDA is reviewing the company’s full approval application on Genmab-partnered Tivdak. Under its priority review timeline, the FDA is assessing whether to convert Tivdak’s accelerated approval into a full nod to treat ...
- Source: drugdu
- 124
- January 11, 2024
BIO-THERA Signs License and Commercialization Agreement with Macter for BAT1706

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”, today announced that it has entered into a license and commercialization agreement with Macter International Limited (“Macter”) for BAT1706, an Anviva reference product. The Company announced today that it has entered into a license and commercialization agreement with Macter International Limited (“Macter”) for BAT1706, a biosimilar developed with reference to Avastin® bevacizumab. Under the terms of the agreement, Macter will have exclusive distribution and marketing rights for BAT1706 in Pakistan and Afghanistan. BAT1706 has completed global Phase III clinical studies, demonstrating a high degree of safety, efficacy, and immunogenicity similarity to the originator, and BAT1706 (PuperChi®) has been approved for marketing by the National Drug Administration (NMPA) of China in November 2021, and BAT1706 (Avzivi®) has been approved for marketing by the U.S. Food and ...
- Source: drugdu
- 83
- January 5, 2024

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