News & Events.

20 May.

Japanese physicians regularly request information on quality, efficacy, safety and cost burden to the patient when adopting or prescribing biosimilars, demonstrates a recent survey [1]. Higher biosimilars uptake may be achievable if such information was made more accessible and digestible.

20 May.

This article, the last in a series on the nomenclature of biological and biosimilar medicines in various Latin American countries based on the study by Iglesias Galiano M in 2021, analyses the management and implementation of the nomenclature of biological and biosimilar medicines in Peru [1].

20 May.

As the largest country in South America, Brazil is an important market for the pharmaceutical industry, but the biosimilars still represent less than 2% of the total biological drug market in the country [1]. 

20 May.

Regulatory bioequivalence rules for generics are well established and recognized. However, proving bioequivalence may not always be so easy, especially with drugs with a narrow therapeutic index (NTI) [1].

20 May.

In April 2022, global pharmaceutical company, Lupin announced that it has entered a strategic partnership with China’s Yabao Pharmaceutical Company. Together, the companies will work to meet the growing demand for quality drugs with paediatric formulations in Chinese markets.

19 May.

Abstract
Detailed and accurate structural characterization of biopharmaceuticals is of paramount importance for product definition, assessment of impurities and achieving in-depth understanding of manufacturing processes. But how can we have confidence in the data obtained from characterization studies? The expectation from regulatory authorities when assessing methods for product characterization is that there will be some demonstration of their suitability to the task in hand. Here we look at those expectations and what steps can be taken to give confidence to the data produced by these analytical methods.

Keywords: analytical development; mass spectrometry; process related impurities; structural characterization

16 May.

Several new adalimumab biosimilar products are preparing to launch in Canada, the US and Europe, from manufacturers including BIOJAMP, Alvotech and Celltrion.

16 May.

Repurposing generic drugs for new indications could save time and money compared to developing new treatments and represent a cost-effective way of addressing unmet medical needs, argues a new article by a University of Michigan professor [1].

16 May.

Innovent and Eli Lilly have announced final clinical results for their sintilimab plus bevacizumab biosimilar injection, which has been accepted by China’s National Medical Products Administration (NMPA).

16 May.

In late-March and mid-April 2022, Biosimilar Solutions Inc (Biosimilar Solutions) announced the start of its registrational clinical trials for BSC1020 and BSC0826 biosimilar filgrastim and on 14 March 2022, OcyonBio LLC (OcyonBio) announced a manufacturing and operations agreement to develop biosimilar drug product facilities for Biosimilar Solutions in Puerto Rico.

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