This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
… Coherus BioSciences plans to sell a biosimilar version of Humira at a steep discount, STAT reports , and the company will work with Mark Cuban’s generic drug company to make the medicine available directly to consumers for even less. Neither vaccine is currently available for use.
Last year was a positive year for biopharmaceutical companies, particularly those with Covid-19 vaccines. As a result of huge global sales of mRNA Covid-19 vaccines, the split in profits between Pfizer and BioNTech’s Comirnaty contributed towards revenues of $81.3bn and $22.4bn last year, respectively. YoY revenue growth.
As Big Molecule Watch continues to push past the bounds of biosimilars and into biologics, we are proud to announce the publication of two additional trackers concerning vaccines: the Vaccine Patent Litigation tracker and the Vaccine Patent PTAB tracker. The post Now Available!
Any authorization for drugs, vaccines, and medical devices issued pursuant to the interim orders are also set to terminate when the respective interim order expires or is withdrawn. Drugs and Vaccines. Both interim orders are set to expire 1 year after they were issued, or sooner if withdrawn by the Minister.
Expanding use of the 15-valent pneumococcal conjugate vaccine (PCV15) or 20-valent pneumococcal conjugate vaccine (PCV20) to all United States adults aged 50 to 64 years would result in modest budget increases over a 3-year period.
Located at the TÜBITAK MAM Gebze campus in Kocaeli province close to Istanbul, the MEDIBIYO facility can generate biotechnological drugs and vaccines that align with good manufacturing practice (GMP) standards, stated the Turkish publication. Ready to commence operation, this centre supports several industrial entities in the country.
Marmara Research Center (MAM) and The Scientific and Technological Research Council of Türkiye (TÜBITAK) have commenced Medical Biotechnology Research Center (MEDIBIYO) for the production of drugs and vaccines on a pilot scale, reported Daily Sabah. Ready to commence operation, this centre supports several industrial entities in the country.
alleging that Pfizer’s respiratory syncytial virus (“RSV”) vaccine ABRYSVO infringes four U.S. patents covering GSK’s rival RSV vaccine, AVREXY. 8,563,002, 11,261,239, 11,629,181, and 11,655,284, as claiming inventions relating to compositions used in RSV vaccines, and methods for preparing those compositions. Patent Nos.
This downturn in market cap was attributed to a decline in the demand for Covid-19 vaccines and therapies. However, the company is anticipated to experience recovery as it awaits regulatory approval from the FDA, expected in May 2023, after receiving priority review for its respiratory syncytial virus (RSV) vaccine.
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
Adoption of biosimilars in the US has been notoriously slow, but biosimilars manufacturers and outside observers expect this to change rapidly in the coming years. One way in which the pharmaceutical industry and regulators have reacted is by developing or facilitating the development of biosimilars. The short story so far.
Namit Joshi, Vice Chairman, Pharmexil, said, “The Indian pharmaceutical industry has solidified its global position as the ‘Pharmacy of the World’ and earned recognition as the ‘Healers of the World’ through its exceptional contribution to COVID-19 vaccine distribution. With exports nearing $27.84
Many millions of people are vaccinated against COVID-19, thanks to a messenger RNA (mRNA) encapsulated within a lipid nanoparticle. As the demand for biologics and biosimilar drugs grows, an even greater degree of analytical data is sought, which is one reason for our recent acquisition of light-scattering leader, Wyatt Technology.
The session, which was entitled “Decoding the Logic: An Overview of Biologics and Biosimilars,” described clinical applications and economic impacts associated with biologics and biosimilars over the last 10 to 15 years, as well as outlined what skills effectively contribute to their management and understanding.
Biologics and biosimilars – the basics Biologic medicines – “biologics” for short. And what about “biosimilars” ? Read on to learn some of the basics about biologics, biosimilars and why patients taking them can be confident in their quality. What are biosimilars? You’ve probably seen commercials for some of them on TV.
Renowned for its extensive production of generic drugs and vaccines, the sector has played a pivotal role in addressing global healthcare demands. As of 2024, India has produced nearly half of the eight billion vaccine doses distributed worldwide, cementing its reputation as a reliable healthcare contributor.
sales of its biosimilar version of AbbVie’s blockbuster arthritis treatment Humira , STAT reports. That led to less uptake of biosimilar versions of Humira in the U.S., … Boehringer Ingelheim will lay off an undisclosed number of sales reps due to poor U.S. including Boehringer’s Cyltezo.
The biosimilar demonstrated comparable efficacy and safety to Stelara in a phase 3 clinical trial, supporting its FDA approval. Steqeyma provides a new dosage form and strength, enhancing treatment flexibility for young patients with chronic inflammatory conditions.
The introduction of the human papillomavirus (HPV) vaccine marked a major turning point, contributing to nearly a 50% reduction in incidence rates and a 70% decrease in mortality since the 1950s.
In my role at Sandoz, I work with teams that are passionately trying to drive healthcare sustainability through the increased use of high-quality biosimilars. 7 With a typical price difference between reference biologics and biosimilars in the range of -15% to -80%, the immediate potential budget impacts are in the tens of billions.
The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world. The first therapy that delays the onset of type 1 diabetes received approval from the U.S. As of 2019, about 1.9
German injectable medicines specialist Fresenius Kabi has made a pair of deals to kickstart its new strategic direction, including a majority stake in mAbxience that bolsters its position in biosimilars. The post Deals build Fresenius Kabi’s position in biosimilars, medtech appeared first on.
Scientific sessions focused on regulatory policies, mRNA technology, cell therapy, biologics and biosimilars, biomanufacturing, and analytical validation. The conference also featured BioPitch, a platform for biotech startups, and Catalyst Connect Hour, facilitating networking opportunities.
Our leadership in vaccine supply to WHO, coupled with meeting the generics demands of the USA, Britain, and Europe, underscores our pivotal role in healthcare accessibility. The significant growth in biosimilars approvals and manufacturing further enhances patient access to biopharmaceuticals.
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
Practising QbD in biosimilar product development. One area in which QbD should be practised is that of biosimilars, also known as follow-on biologics or subsequent entry biologics. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
While the overall MG market is expected to experience growth until 2034, continued generic erosion and the entry of biosimilars will be important barriers to growth. Generic erosion and the entry of biosimilars are expected to be particularly significant in the US MG market. s Zilbrysq (zilucoplan). s Zilbrysq (zilucoplan).
The Swiss pharma group said this morning that the separation “is in the best interest of shareholders” and will create the number one generics company in Europe and a leader in biosimilars, whilst allowing Novartis to focus on its patented medicines business. billion by 2024.
CHMPs opinion for biosimilar medicines Additionally, the committee recommended nine biosimilar medicines. The CHMP also recommended Oczyesa (octreotide) to treat adults with acromegaly, a disorder characterised by excessive growth hormone in the body. This included Dazublys (trastuzumab) for metastatic and early breast cancer.
A magnifying glass examining a vintage vaccine vial surrounded by four minimalistic chart icons, symbolizing healthcare, medicine, and analytics in the context of global health monitoring. Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1). Specifications.
We believe that implementing a fresh PLI scheme for vaccines and biopharmaceutical raw materials is vital now to put the focus back on value-added domestic production with India-for-India and India-for-the-world production. This would stimulate new investments in both R&D and production initiatives.
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
Related Videos Related Content Advertisement June 11th 2025 Perioperative Nivolumab Shows Long-Term EFS, Favorable OS in Resectable NSCLC Luke Halpern, Assistant Editor June 3rd 2025 S2.
Investing in cutting-edge research, particularly in biosimilars, novel biologics, and cell and gene therapies, will be crucial. Serum Institute of India (SII) is the worlds largest vaccine manufacturer. India is the largest vaccine producer in the world and accounts for 60 per cent of the global vaccine production.
Related Videos Related Content Advertisement June 10th 2025 Inpatient Biosimilar Use Grows, Offering Cost-Saving Opportunities for Health Systems Aislinn Antrim, Managing Editor June 3rd 2025 S2. December 21, 2004. Subscribe Now!
Additionally, the industry is set to make notable progress in cutting-edge areas such as CAR-T cell therapy, mRNA vaccines, and the development of complex molecules, which hold immense potential for driving future growth. The patent expiries of blockbuster biologics by 2025 present a significant growth avenue in the global biosimilars market.
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
Demand for cell lines “in drug development , vaccine production, and therapeutic research is surging”, setting the market up for significant expansion, Ghosh noted. The increased spending on biosimilar R&D from exiting biopharmaceutical companies would enhance the market, the report stated.
Related Videos Related Content Advertisement June 16th 2025 FDA Approves Ustekinumab-Stba, Biosimilar to Stelara, for Pediatric Patients With PsO or PsA Gillian McGovern, Associate Editor June 3rd 2025 S2. Subscribe Now!
News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)
Literature suggests a 3% difference in the rate of FN between CSF agents filgrastim (Neupogen; Amgen)/filgrastim biosimilars and pegfilgrastim (Neulasta; Amgen)/pegfilgrastim biosimilars. Utilizing colony-stimulating factors (CSFs) decreases the incidence of severe FN.
We organize all of the trending information in your field so you don't have to. Join 11,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content