article thumbnail

Indian pharma manufacturing: rising investment in Andhra Pradesh

Pharmaceutical Technology

Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. US reliance on India for generic drugs could have supply chain security and quality implications for critical medicines.

article thumbnail

Sym-021 by Les Laboratoires Servier for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

The therapeutic candidate targets immune checkpoint, programmed cell death protein 1 (PD1). The company also provides generic drugs and contract development and manufacturing services across its global network. It is administered as an intravenous infusion. It is developed based on sympress platform technology.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Quality by design with a focus on biosimilars

Pharmaceutical Technology

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

article thumbnail

Sanofi snaps up acne vaccine developer Origimm Bio

pharmaphorum

The French group said that ORI-001, a vaccine based on recombinant proteins from the Cutibacterium acnes (formerly Propionibacterium acnes ) bacterium that is often found in acne lesions, could be the first ever vaccine for the condition. C acnes is implicated in moderate to severe acne, which is difficult to treat.

article thumbnail

The New Frontier in Drug Development: Understanding Biologics and Small Molecules

Cloudbyz

Here’s an overview of the differences between them: Composition and Size : Small Molecules: These are chemically synthesized drugs that are generally low in molecular weight, typically less than 900 Daltons. Biologics: Biologics are large, complex molecules, often proteins, that are produced using living cells.

article thumbnail

Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “genericdrugs of the biopharma world.

article thumbnail

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

Stelara’s patents are expiring in September 2023, while a handful of biosimilar drugs are in late-stage development or seeking FDA approval. The FDA approved the drug over a decade ago in September 2009. billion the drug generated in 2021. Johnson & Johnson’s total global earnings from Stelara were $9.72

Sales 98