TNF inhibitors

HUMIRA (Adalimumab) Biosimilars Report 2021: Focus on Approved & Launched, Investigational & Research Use, Inactive/Terminated/Withdrawn, Industry/Non-Industry Partnerships - ResearchAndMarkets.com

Retrieved on: 
Friday, July 30, 2021

The "HUMIRA (Adalimumab) Biosimilars: Focus on Approved & Launched Biosimilars, Investigational & Research Use Biosimilars, Inactive/Terminated/Withdrawn Biosimilars, Industry/Non-Industry Partnerships" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "HUMIRA (Adalimumab) Biosimilars: Focus on Approved & Launched Biosimilars, Investigational & Research Use Biosimilars, Inactive/Terminated/Withdrawn Biosimilars, Industry/Non-Industry Partnerships" report has been added to ResearchAndMarkets.com's offering.
  • The "Adalimumab Biosimilars: Focus on Approved & Launched Biosimilars, Investigational & Research Use Biosimilars, Inactive/Terminated/Withdrawn Biosimilars, Industry/Non-Industry Partnerships" report features an extensive study of the current developer landscape and clinical research scenario related to all the follow-on products of the blockbuster biologic drug, HUMIRA, which are either available or under development.
  • An analysis of the various partnerships related to adalimumab biosimilars, based on parameters, such as year of partnership, type of partnership, and geographical locations of partnering entities.
  • A detailed assessment of the various marketing and distribution agreements inked in relation to HUMIRA biosimilars, highlighting the key players involved.

China's Infliximab Market Investigation Report 2021-2025 - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 29, 2021

The "Investigation Report on China's Infliximab Market 2021-2025" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Investigation Report on China's Infliximab Market 2021-2025" report has been added to ResearchAndMarkets.com's offering.
  • By 2020, Janssen Biologics BV is the only manufacturer in the Chinese Infliximab market.
  • According to the market research, since Infliximab entered the Chinese market in 2007, its sales have had an increasing trend.
  • 2 Sales of Infliximab in China, 2016-2020
    2.3 Sales of Infliximab by Dosage Form in China, 2016-2020
    3 Analysis of Major Infliximab Manufacturers in China, 2016-2020
    4 Prices of Infliximab for Different Manufacturers in China, 2020-2021
    5 Prospect of Chinese Infliximab drug Market, 2021-2025
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210729005802/en/

IMIDomicsTM Closes $16.5 Million Series A Financing to Advance its Precision Discovery Platform for Immune-Mediated Inflammatory Diseases

Retrieved on: 
Tuesday, July 27, 2021

IMIDomics Inc., a drug discovery company focused on patients with immune-mediated inflammatory diseases (IMIDs), has announced the completion of a $16.5 million Series A financing round.

Key Points: 
  • IMIDomics Inc., a drug discovery company focused on patients with immune-mediated inflammatory diseases (IMIDs), has announced the completion of a $16.5 million Series A financing round.
  • IMIDomics Precision Discovery Platform combines and analyzes clinical, epidemiologic, and biomolecular data to uncover new insights about IMIDs including lupus, Crohns disease, rheumatoid arthritis, and ulcerative colitis.
  • IMIDomics has established a Precision Discovery Platform that leverages patient data to reveal the fundamental mechanisms that drive immune-mediated inflammatory diseases.
  • This integrated capability, called the IMIDomics Precision Discovery Platform, enables precision medicine for IMID patients and will lead to therapies that address needs not addressed by current medicines.

Sorrento Announces Its Partner Mabpharm Has Received Marketing Approval In China For Infliximab Biobetter

Retrieved on: 
Tuesday, July 20, 2021

China National Medical Product Administration (NMPA) has granted Mabpharm approval to marketINFLIXIMAB biobetter in China.

Key Points: 
  • China National Medical Product Administration (NMPA) has granted Mabpharm approval to marketINFLIXIMAB biobetter in China.
  • Sorrento holds commercialization rights outside of China and intends to meet with regulatory agencies to determine best path to registration for the US and Europe.
  • SAN DIEGO, July 20, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics (Nasdaq: SRNE) announced today that its partner Mabpharm Ltd (HK:2181) has received approval of its New Drug Application for its infliximab biobetter antibody in China.
  • Sorrento holds exclusive commercial rights to this product outside of China and plans to file a Biologics License Application (BLA) for the infliximab biobetter antibody in the United States and Europe in 2021.

Global Ulcerative Colitis Clinical Landscape Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Monday, July 12, 2021

The "Disease Analysis: Ulcerative Colitis" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Disease Analysis: Ulcerative Colitis" report has been added to ResearchAndMarkets.com's offering.
  • As specialty products, therapies for ulcerative colitis (UC) can be expensive, and formulary positioning is paramount to product uptake.
  • Payers are settled in vital contracts that lead them to prioritize broad immunology drugs Humira and Remicade.
  • This has posed a high barrier to newer entrants to the market, which cannot compete in volume and rebates.

Alvotech Initiates Clinical Studies for AVT04, a Proposed Biosimilar to Stelara® (Ustekinumab)

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Tuesday, July 6, 2021

Alvotech, the Iceland-based biosimilar company, today announced that the first patient has been dosed in the comparative, confirmatory efficacy and safety clinical study (AVT04-GL-301) for AVT04, Alvotechs proposed biosimilar to the reference product Stelara.

Key Points: 
  • Alvotech, the Iceland-based biosimilar company, today announced that the first patient has been dosed in the comparative, confirmatory efficacy and safety clinical study (AVT04-GL-301) for AVT04, Alvotechs proposed biosimilar to the reference product Stelara.
  • In parallel, Alvotech is also conducting a PK similarity study (AVT04-GL-101) to demonstrate equivalent PK endpoints between the proposed biosimilar and the reference product Stelara.
  • AVT04 is the second proposed biosimilar product from Alvotech entering clinical studies, the first being AVT02, a proposed biosimilar to Humira.
  • Rbert Wessman, founder and Chairman of Alvotech, commented:
    As a founder, I am extremely proud to see us enter the second proposed biosimilar product into clinical trials.

Alvotech Bondholders Convert More Than $100m at Pre-Money Valuation of $2.7bn

Retrieved on: 
Friday, June 25, 2021

In May 2021, Alvotech USA Inc. filed a lawsuit in the Eastern District of Virginia seeking to invalidate four of AbbVies key patents.

Key Points: 
  • In May 2021, Alvotech USA Inc. filed a lawsuit in the Eastern District of Virginia seeking to invalidate four of AbbVies key patents.
  • The lawsuit also argues that AbbVies patent strategy, which has been under recent Congressional scrutiny , renders its Humira patents unenforceable.
  • Further, the lawsuit points out that AbbVie has failed to sue Alvotechs US affiliate (the actual BLA applicant) at all.
  • Alvotech is a multinational biopharmaceutical company focused on the development and manufacture of high quality biosimilars for global markets.

Alvotech Reaches Primary Completion Date in Its Switching Study for AVT02, a Proposed Interchangeable Biosimilar to AbbVie’s Humira®

Retrieved on: 
Tuesday, June 15, 2021

Alvotech, today, announced reaching the primary completion date in the switching study for AVT02, the companys proposed interchangeable biosimilar to Humira.

Key Points: 
  • Alvotech, today, announced reaching the primary completion date in the switching study for AVT02, the companys proposed interchangeable biosimilar to Humira.
  • Alvotech is the only known company that has both developed a biosimilar candidate for the high-concentration Humira and is executing a switching study to support approval as an interchangeable product.
  • The completion of the comparative treatment phase of the switching study is a key milestone in our program for our AVT02 interchangeable biosimilar candidate.
  • In order to be considered interchangeable, a biosimilar must meet additional requirements, including the execution of an interchangeable switching study, utilizing the innovator and biosimilar product in patients.

Adalimumab Biosimilar Market Insight Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Thursday, June 10, 2021

The "Adalimumab - Biosimilar Insight, 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Adalimumab - Biosimilar Insight, 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This "Adalimumab- Biosimilar Insight, 2021," report provides comprehensive insights about 35+ companies and 35+ marketed and pipeline drugs in Adalimumab Biosimilars landscape.
  • Abrilada is an FDA-approved biosimilar version of adalimumab.
  • Bio-Thera Solutions has received approval from the country's National Medical Products Administration (NMPA) for Qletli, a biosimilar to AbbVie's Humira (adalimumab).

Bio-Thera Solutions Initiates Phase III Clinical Trial for BAT2506, a Proposed Biosimilar of Simponi® (Golimumab)

Retrieved on: 
Tuesday, June 8, 2021

Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase III clinical study for BAT2506, a proposed biosimilar of Simponi (golimumab).

Key Points: 
  • Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase III clinical study for BAT2506, a proposed biosimilar of Simponi (golimumab).
  • Patient enrollment in our Phase III clinical trial for BAT2506 is another important achievement for Bio-Thera as it is our third proposed biosimilar to enter a global Phase 3 study, said Shengfeng Li, CEO, Bio-Thera Solutions.
  • Bio-Thera Solutions is developing several additional proposed biosimilars, including a bevacizumab biosimilar and a tocilizumab biosimilar that have both successfully completed global Phase III clinical trials.
  • 2 QLETLI is a registered trademark of Bio-Thera Solutions, Ltd.
    3 is a registered trademark of Bio-Thera Solutions, Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210608005454/en/