Biosimilar

Pharmaceutical Analytical Testing Outsourcing Global Market to 2028 - Sector to Reach $12.2 Billion by 2028 at a CAGR of 7.51%

Retrieved on: 
Thursday, February 9, 2023

As an extension of contract research organizations, pharmaceutical analytical testing outsourcing services have begun replacing a significant portion of in-house analytical development and testing.

Key Points: 
  • As an extension of contract research organizations, pharmaceutical analytical testing outsourcing services have begun replacing a significant portion of in-house analytical development and testing.
  • Key Questions Answered in This Report:
    How has the global pharmaceutical analytical testing outsourcing market performed so far and how will it perform in the coming years?
  • What has been the impact of COVID-19 on the global pharmaceutical analytical testing outsourcing market?
  • What is the structure of the global pharmaceutical analytical testing outsourcing market and who are the key players?

Dr. Reddy’s successfully completes full set of clinical studies of its rituximab biosimilar for filing in the U.S., Europe

Retrieved on: 
Friday, January 20, 2023

Reddy’s”), a global pharmaceutical company, announced that it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, Europe and other regions.

Key Points: 
  • Reddy’s”), a global pharmaceutical company, announced that it has successfully completed the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, Europe and other regions.
  • Dr. Reddy’s rituximab biosimilar has already been approved for marketing in India and over 25 emerging markets.
  • The company undertook further clinical development to meet regulatory requirements of highly regulated markets.
  • The successful completion and positive outcome of these clinical studies highlights our capability for global clinical development of biosimilar products for highly regulated and global markets.

EMA Confirms Acceptance of Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab)

Retrieved on: 
Thursday, February 9, 2023

The companies anticipate that the EMA could recommend approving a marketing authorization for AVT04 as soon as in the second half of 2023.

Key Points: 
  • The companies anticipate that the EMA could recommend approving a marketing authorization for AVT04 as soon as in the second half of 2023.
  • “We are pleased to be able to move closer to making AVT04 available to patients in Europe," said Joseph McClellan, Chief Scientific Officer of Alvotech.
  • As of December 2022, the companies had launched marketing and sales of the first biosimilar in the partnership, high-concentration adalimumab, in 16 countries in Europe .
  • Earlier in May 2022 , Alvotech also announced positive top-line results from a pharmacokinetic (PK) similarity study for AVT04.

Alvotech and Bioventure Announce Approval of AVT02 (adalimumab) as Simlandi in Saudi Arabia

Retrieved on: 
Tuesday, January 24, 2023

The biosimilar will be marketed as Simlandi™ in Saudi Arabia.

Key Points: 
  • The biosimilar will be marketed as Simlandi™ in Saudi Arabia.
  • “The approval of Simlandi by the SFDA marks an important milestone for local patients and physicians,” said Ashraf Radwan, Division CEO of GlobalOne Healthcare Holding.
  • Bioventure and Alvotech have previously entered into license agreements for multiple biosimilars.
  • Under the terms of the license agreement for AVT02 between Alvotech and Bioventure, Alvotech will handle development and manufacturing, while Bioventure will be responsible for the commercialization of the biosimilar.

Single-use Bioreactors Global Market Report 2022: Increasing Adoption of SUBs Among Small Companies and Startups Bolsters Growth - ResearchAndMarkets.com

Retrieved on: 
Monday, January 16, 2023

The global single-use bioreactors market size is expected to reach USD 12,062.5 million by 2030.

Key Points: 
  • The global single-use bioreactors market size is expected to reach USD 12,062.5 million by 2030.
  • Owing to the rising demand for biopharmaceuticals, coupled with increasing investments in single-use technologies, the market for single-use bioreactors is expected to witness a significant growth throughout the forecast period.
  • Additionally, the single-use bioreactors market is projected to benefit from new opportunities brought on by license termination and emerging markets.
  • Thus, propelling the market growth
    Chapter 5 Single - Use Bioreactors Market: Product Business Analysis
    Chapter 6 Single - Use Bioreactors Market: Type Business Analysis
    Chapter 7 Single - Use Bioreactors Market: Type Of Cell Business Analysis
    Chapter 8 Single - Use Bioreactors Market: Molecule Type Business Analysis
    Chapter 9 Single - Use Bioreactors Market: Application Business Analysis
    Chapter 10 Single - Use Bioreactors Market: Usage Type Business Analysis
    Chapter 11 Single - Use Bioreactors Market: End - Use Business Analysis
    Chapter 12 Single - Use Bioreactors Market: Regional Business Analysis

EQS-News: Formycon and Fresenius Kabi conclude global commercialization partnership for FYB202, a biosimilar candidate to Stelara®1 (ustekinumab)

Retrieved on: 
Thursday, February 2, 2023

Formycon and Fresenius Kabi conclude global commercialization partnership for FYB202, a biosimilar candidate to Stelara®1 (ustekinumab)

Key Points: 
  • Formycon and Fresenius Kabi conclude global commercialization partnership for FYB202, a biosimilar candidate to Stelara®1 (ustekinumab)
    The issuer is solely responsible for the content of this announcement.
  • Formycon and Fresenius Kabi conclude global commercialization partnership for FYB202, a biosimilar candidate to Stelara®1 (ustekinumab)
    Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY), as the exclusive owner of the global commercial rights to FYB202, a biosimilar candidate to Stelara® (ustekinumab), announced the conclusion of a global license agreement with Fresenius Kabi AG (“Fresenius Kabi”).
  • Provided successful approval by the respective health agencies, Fresenius Kabi will commercialize FYB202 in key global markets.
  • Fresenius Kabi is a global healthcare company that specializes in pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions.

Alvotech and Fuji Pharma Expand Partnership Adding a New Biosimilar Candidate

Retrieved on: 
Friday, January 13, 2023

REYKJAVIK, Iceland and TOKYO, Jan. 13, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Japanese pharmaceutical company Fuji Pharma Co., Ltd. (“Fuji”, Tokyo Stock Exchange: 4554) have decided to expand their existing exclusive commercialization partnership covering Japan, by adding a new undisclosed biosimilar candidate.

Key Points: 
  • REYKJAVIK, Iceland and TOKYO, Jan. 13, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Japanese pharmaceutical company Fuji Pharma Co., Ltd. (“Fuji”, Tokyo Stock Exchange: 4554) have decided to expand their existing exclusive commercialization partnership covering Japan, by adding a new undisclosed biosimilar candidate.
  • “We are pleased to expand our successful collaboration with Fuji.
  • Just recently, we announced the submission of an application for marketing approval in Japan for the first biosimilar candidate developed under our partnership,” said Robert Wessman, Founder, CEO and Chairman of Alvotech.
  • The exclusive partnership agreement was first announced by Alvotech and Fuji in November 2018 , and previously extended in December 2020 and February 2022 , now covering seven biosimilars including the new candidate, to be developed and manufactured by Alvotech, and commercialized by Fuji in Japan.

Alvotech Initiates Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria®

Retrieved on: 
Wednesday, January 11, 2023

REYKJAVIK, Iceland, Jan. 11, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab).

Key Points: 
  • REYKJAVIK, Iceland, Jan. 11, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab).
  • The study will assess the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® in healthy adult subjects.
  • “We are delighted with the progress of the AVT05 development program,” said Joseph McClellan, Chief Scientific Officer.
  • Alvotech’s first marketed product, a biosimilar to Humira® (adalimumab), has been launched in Europe and Canada, and approved in 35 countries world-wide.

Coherus Agrees to Acquire Exclusive U.S. Commercial Rights to Eylea® Biosimilar FYB203 from Klinge Biopharma

Retrieved on: 
Monday, January 9, 2023

REDWOOD CITY, Calif., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or Coherus BioSciences, Nasdaq: CHRS) announced today that it has executed a binding term sheet with Klinge Biopharma GmbH (Klinge Biopharma) for the exclusive commercialization rights to FYB203, a biosimilar candidate to Eylea® (aflibercept), in the United States.

Key Points: 
  • REDWOOD CITY, Calif., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or Coherus BioSciences, Nasdaq: CHRS) announced today that it has executed a binding term sheet with Klinge Biopharma GmbH (Klinge Biopharma) for the exclusive commercialization rights to FYB203, a biosimilar candidate to Eylea® (aflibercept), in the United States.
  • The parties expect to complete the transaction in Q1 2023, and Coherus plans to file a Biologics License Application with the U.S. Food and Drug Administration later this year.
  • Coherus intends to launch the product at Eylea® biosimilar market formation, currently expected to be in 2025, if approved.
  • Coherus will also make other regulatory and launch milestone payments and share profits approximately equally in consideration for the commercialization rights to FYB203 in the United States.

Implications of Biosimilar Availability in the United States' Ophthalmology Markets Highlighted in New Spherix Global Insights Study

Retrieved on: 
Tuesday, January 10, 2023

EXTON, Pa., Jan. 10, 2023 /PRNewswire/ -- Ophthalmologists saw the entry of the first biosimilars into the armamentarium in 2022 with the launch of Biogen and Samsung's Byooviz and Coherus Bioscience's Cimerli (both biosimilars to Genentech's Lucentis). But are they being used?

Key Points: 
  • According to the December 2022 Spherix report, while access has opened to biosimilars in ophthalmology since last wave (fielded November 2021) comfort and familiarity ratings with the class has gone down.
  • There is minimal familiarity with the pipeline biosimilar manufacturers Biogen, Bausch, Amgen, Samsung, Sandoz, Coherus Biosciences, Lupin, Alvotech, Celltrion, Xbrane, and Formycon.
  • Though ophthalmologists have now had access to an FDA approved biosimilar for half a year, the future of biosimilars in ophthalmology remains uncertain.
  • Continued education and financial incentives will become essential if biosimilars are to become a mainstay in ophthalmological markets.