With so many challenges in research , still class of drug is experienceing the maximum funding with great Retuns on Investment(ROI). Keeping these points in mind we are organizng the 13th International Conference on Biologics and Biosimilars during October 24-25, 2018 at Boston, USA with the theme: Emerging Trends in Biosimilars Approvals, Market and Pricing.
The development of biologics calls for overcoming many challenges. With initial steps of concepts of biologics, their considerations, essentials for early clinical developments it is very much needed that proper scientific and strategic approaches are taken for the successful development of follow-on-biologics. Moreover, the need for overcoming the challenges continues in the late clinical steps, drug safety factors and labelling requirements. Also it is much required now to develop a drug product in accordance to Quality by Design (QbD).
This biosimilars conference will look at the facets of current challenges in biosimilar development. This biosimilar conference will focus on multiple aspects of biosimilar product development to successfully deliver safe, potential and efficacious biologic products to the market.
With less than 10 biosimilars approved by USFDA, the drug class is still ints infancy. However, market penetration rate is quite high with more biologic products going off patent. Amgen Inc.’s (AMGN) Amjevita, a biosimilar of AbbVie’s (ABBV) Humira (adalimumab) secured FDA approval in September 2016, but is yet to be marketed due to legal hurdles. Production bottlenecks are the second most obvious challenge since biosimilar manufacturing is complex, as the drugs are derived from living cells. This often leads to higher manufacturing costs and concerns about scalability potential of the manufactured biosimilars. Nevertheless, pricing is an important parameter requiring optimization. Pfizer Inc. (PFE) secured approval for Inflectra (infliximab-dyyb), its biosimilar of Johnson & Johnson’s (JNJ) Remicade, in April 2016. However, the price of Inflectra is only 15% lower than that of Remicade, and the much-anticipated launch dented the hopes of deep discounts from biosims. Generics usually cost 80% less than branded drugs.
For details on our sponsorship packages take a look at our brochure : Biosimilars 2018 Sponsorship
- Current Challenges in Developing Biosimilars
- Biosimilars Analytical Strategies
- Emerging Biosimilars in Therapeutics
- Regulatory Approach for Biosimilars
- Legal Issues and BPCI Act
- Biosimilars Research Pipeline
- Globalization of Biosimilars
- Clinical Development Of Biosimilars
- Intellectual Property Rights
- Bioequivalence Assessment
- BCS and IVIVC Based Biowaivers
- Biosimilar Companies and Market Analysis
- Challenges in Biosimilars Pharmacovigilance
- Brexit Effect on Biosimilars
- Entrepreneurs Investment Meet
- Abstracts Submission
- Scientific Program
- Organizing Committee
- Call for Abstracts
- Brochure & Contact Details
Previous Speakers at Biosimilars Conference