Analysis of biosimilars and biologics forms to be one of the most important aspects towards the biologics and biosimilar development process. Biosimilars analytical methods for process development and validation as well as use of production technologies such as disposables and supply chain logistics can help companies establish facility flexibility.
This biosimilars global event also includes Bio analytical methods, Formulation, Bioassay for comparability and potency testing, GMP protein analysis, LC/MS analysis for discovery, preclinical, and clinical programs.
Development of biologics is considerably more expensive and time-consuming than that of small molecules. The latter contain only carbon, oxygen and nitrogen, which are easier to synthesize with low batch-to-batch variability
Despite the high cost of development, due to their targeted nature with high efficacy, biologics are now taking on an increasingly important role in the treatment of common and/or serious diseases.
Once these criteria are fulfilled, these biosimilars are often given similar indications as the originator drugs in order to reduce the development cost and hence the market price. Once approved, the inherent nature of these complex molecules calls for continuing surveillance to detect allergic reactions or rare events due to immunogenicity or other untoward reactions, which may not be detectable during the development stage. Besides, the batch-to-batch variations may also lead to efficacy and safety issues in the post marketing phase.
Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.
Biosimilars and bio betters are both variants of a biologic; with the former being close copies of the originator, while the latter ones have been improved in terms of efficacy, safety, and tolerability or dosing regimen.
Some evidence points to the fact that the first biosimilars were not as good as their branded counterparts. Whereas in case of Bio betters gain in effectiveness may come with a larger price tag, as the drug would be touted as an improvement on the current standard of treatment, and not a direct competitor in the market. This does nothing to help the cost-conscious consumer looking for cheaper alternatives. Now the question arise Biosimilars or Bio better? Accessibility & similarity or efficacy & improvement what will you choose?
Patents for several biologic blockbusters will expire in the next few years. The arrival of biosimilars, the biologic equivalent of chemical generics, will have an impact on the current biopharmaceuticals market. Five core capabilities have been identified as paramount for those companies aiming to enter the biosimilars market: research and development, manufacturing, supporting activities, marketing, and lobbying. Understanding the importance of each of these capabilities will be key to maximizing the value generated from the biologics patent cliff.
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.
Biologic trials require a customized approach based on the therapeutic indication and study specific goals. The CRO must work with the sponsor to develop an effective plan and execution strategy for these study types that includes subject recruitment, regulatory, clinical safety monitoring, specialized pharmacy expertise, and bio analytical support while ensuring subject safety throughout the entire trial. This is best accomplished with a detailed risk assessment to ensure all the bases are covered. The risk assessment isn’t just done once and then forgotten, but is a living document that is updated as new information about the molecule is gathered.
Good Manufacturing practices aims at both production and Quality Control. Fact about Current Good Manufacturing Practices (cGMP) is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. Over the previous decade, a developing offer of the business' R&D yield has comprised of incremental enhancements to existing generic medications instead of new sub-atomic substances. Execution measures that consider just altogether new medications, for example, the quantity of NME endorsements every year miss that move and underestimate the business' R&D Field
“Novel Drug delivery System (NDDS)” refers to the formulations, systems and technologies for transporting a pharmaceutical compound in the body as it is needed to safely achieve its desired therapeutic effects. Drug delivery systems (DDS), are based on approaches that are interdisciplinary and that combine pharmaceutics, bio conjugate chemistry, and molecular biology.
- Nano technology
- Controlling pharmacokinetics and dynamic properties
- Drug Delivery Carriers, Micelles, etc..,,
- Types of dosage forms
- Route of administration