With 10 years now added to its repertoire, European Biosimilars Congress is really turning into a staple meeting where Biosimilars partners accumulate to address the present and future condition of Biosimilars in the Europe.
Event Status: Closed
14 - 15 April 2025
|
Time: 12pm to 2 pm
|
Paris, France.
With 10 years now added to its repertoire, European Biosimilars Congress is really turning into a staple meeting where Biosimilars partners accumulate to address the present and future condition of Biosimilars in the Europe.
The addition of two dedicated streams at the European Biosimilars Congress meeting proved to be highly successful, providing valuable insights from two distinct groups. One group excelled in the scientific and technical aspects, offering in-depth knowledge and expertise in research and manufacturing. The other group excelled in the business and strategic aspects, providing valuable insights into market trends, commercialization strategies, and regulatory considerations. This dual-stream approach allowed participants to gain a comprehensive understanding of both the scientific and commercial aspects of the biosimilars industry. The positive response and knowledge exchange from these two specialized streams contributed to the overall success of the European Biosimilars Congress meeting.
The 2025 establishment of this meeting will enable us to keep on diving further into both the investigation of Biosimilars improvement – and the business requirements for organizations that keep on seeking FDA endorsement.
The Organizing Committee is delighted to invite you to attend the Euro Biosimilars 2025 one of its remarkable Pharmaceutical conferences, to be held during April 14-15, 2025 at Paris, France. European Biosimilars Congress is a global annual event. This Europen Biosimilars Congress 2025 will bring together scientists, researchers, business development managers, CEOs, directors, IP Attorneys, Regulatory Officials and CROs from around the world. Many biologics products are making their entry in the pharma market and experiencing a notable rise in their usage over the conventional medications.
At Euro Biosimilars 2025 meet your target audiences from around the world focused on learning about biologics and Biosimilars. This conference would be your single best opportunity to reach the largest assemblage of participants from the biologics and Biosimilars community.
The Euro Biosimilars 2025 conference will host a diverse range of exhibitors, with over 50+ organizations and international pavilions participating. The exhibition will feature a wide array of industry stakeholders, including equipment manufacturers, suppliers, systems providers, finance and investment firms, R&D companies, project developers, trade associations, and government agencies. This diverse representation underscores the significance and breadth of the biosimilars sector. Attendees can expect to engage with leading companies and institutions from various sectors, fostering collaborations, knowledge exchange, and advancements in the field of biosimilars.
In addition to the products and services you will have access to valuable content, including Keynote Presentations, Product Demonstrations and Educational Sessions from today’s industry leaders.
The Euro Biosimilars 2025 has everything you need, all under one roof, saving you both time and money. It is the event you cannot afford to miss!
In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
The BPCI Act is part of the healthcare reform legislation, which was signed into law on 23 March 2010 by President Barack Obama. The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be ‘highly similar’ (biosimilar) to, or ‘interchangeable’ with, a US Food and Drug Administration (FDA)-licensed biological product.
FDA is still in the process of developing guidelines regarding these types of products and has issued several guidance documents on the subject.
Zarxio (filgrastim-sndz) was the first product approved in the US as a biosimilar in 2015. To date, FDA has approved four biosimilars within the product classes of anti-tumour necrosis factor-alpha (TNF-α) and granulocyte colony-stimulating factor, and a follow-on biological in the product class of insulin for use in the US.
In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally.
EMA first developed guidelines for the approval of biosimilars via an abbreviated registration process during 2005 to 2006, and since then EMA has developed many general and specific guidelines for biosimilars .
Omnitrope (somatropin) was the first product approved in the EU as a biosimilar in 2006. To date, EMA has approved 38 biosimilars within the product classes of human growth hormone, granulocyte colony-stimulating factor, erythropoesis stimulating agent, insulin, follicle-stimulating hormone (FSH), parathyroid hormone and tumour necrosis factor (TNF)-inhibitor, for use in the EU. Three biosimilar approvals have been withdrawn; two for filgrastim biosimilars: Filgrastim ratiopharm in April 2011 and Biograstim in December 2016, and one for a somatropin biosimilar (Valtropin) in May 2012. This leaves a total of 35 biosimilars approved for use in Europe.
For more details visit: https://biosimilars-biologics.pharmaceuticalconferences.com/europe/
