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Sep 22, 20244 min read
Bioconjugates: Combining the Best of Biologics and Small Molecules
Bioconjugates are molecules formed by chemically linking two or more molecules, typically involving a biological molecule like a...
Aug 30, 20244 min read
Pharmacovigilance of Vaccines in the USA (US FDA)
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or...
Aug 30, 20244 min read
Pharmacovigilance of Biologics in the USA (US FDA)
Pharmacovigilance plays a vital role in ensuring the safety and efficacy of biologics, which are complex therapeutic agents derived from...
Aug 23, 20243 min read
Patent Expiry Alert: Blockbuster Drugs Expected to Lose Protection in the Next Five Years
Patent expiry refers to the end of the legal protection period granted to a patented invention or product. When a pharmaceutical company...
Aug 21, 20244 min read
Biosimilars: Affordable and Effective Alternatives to Biologics
Biosimilars are biologic medical products that are highly similar to an already approved reference biologic drug. They are designed to...
Jul 2, 20244 min read
Biologics in Autoimmune Diseases: A New Hope for Patients
Biologics in Autoimmune Diseases:
Jun 27, 20247 min read
Precision Medicine – Key Players and Pipeline
Precision medicine, with its promise of tailoring treatments to individual patient characteristics, is revolutionizing the healthcare...
Jun 26, 20244 min read
Precision Medicine – US FDA Regulations and Reimbursement Policies
Precision medicine represents a transformative approach to healthcare, aiming to tailor treatments to individual patient characteristics,...
Jun 7, 20243 min read
Biopharmaceutical Alliance Launched by India, South Korea, US, Japan, and EU
The global biopharmaceutical sector has taken a significant step towards ensuring a resilient drug supply chain with the formation of the...
Nov 28, 20234 min read
Registration of Biologics in Malaysia (NPRA)
Biologics have emerged as a significant treatment for various diseases in Malaysia. With their increasing relevance in addressing chronic...
Sep 6, 20235 min read
Biologics and Biosimilar Regulations and Registration in South Korea
The Korean pharmaceutical market is estimated to be worth $24.3 billion in 2019, and between 2015 and 2019, it grew at a compound annual...
Sep 1, 20237 min read
Biologics and Biosimilars Regulation and Registration in India (CDSCO)
The size of the Indian biosimilars market, which was anticipated to be worth $349 million in 2022, is expected to increase to $2108...
Aug 31, 20235 min read
Biologics and Biosimilar Regulation and Registration in Japan (PMDA)
With the exception of the United States, Japan's biosimilar business, with a market value of $140 million, accounted for just 5% of the...
Aug 28, 20235 min read
Biologics and Biosimilar Regulations and Registration in the European Union (EU) (EMA)
In 2022, the Europe biosimilar market had a value of almost USD 4601.56 million. In addition, it is anticipated that the biosimilar...
Aug 23, 20235 min read
Biologics and Biosimilars Regulations and Registration in Mexico (COFEPRIS)
Mexico is the second-largest drug market in Latin America, after Brazil. With a compound annual growth rate (CAGR) of 38.7%, the Mexican...
Aug 18, 20235 min read
Biologics and Biosimilars Regulations and Registration in China (NMPA)
In China, 40% of the biologics market comprises biosimilars. The usage of biosimilars in oncology has increased as cancer overtook heart...
Aug 17, 20235 min read
Biologics and Biosimilar Regulations and Registration in Brazil
According to the Drugs Sector Regulation Chamber (CMED) in 2022, the Brazilian pharmaceutical sector generated US $17.2 billion in sales...
Aug 9, 20235 min read
Biologics and Biosimilars Regulations, Registration Process in the USA (FDA)
The size of the U.S. biosimilars market, estimated at USD 6.73 billion in 2021, is expected to increase by USD 9.48 billion in 2022 and...
Jul 27, 20237 min read
Pharmaceutical Regulations and Registration in Australia
The pharmaceutical market in Australia is projected to reach USD 9.78 billion by the end of the year 2023 with the largest market share...
Jun 20, 20232 min read
Expanded Access by USA FDA for Investigational Drugs
In the United States, the approval process for unregistered medicinal products under Early Access Program (EAP) is known as Expanded Access
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