The regulatory process for biologic agents, with approval depending most heavily on demonstration of safety and efficacy in clinical trials, regulatory review of biosimilars focuses on molecular characterization and preclinical studies and pharmacokinetic and pharmacodynamic studies to establish biosimilarity, with additional studies assessing immunogenicity and other potential toxicities; clinical trials are performed if uncertainty remains regarding safety and efficacy of the biosimilar. As noted by the authors, often 50% or more of the data in applications for approval of biosimilar agents concern manufacturing processes. Further, the regulatory approval process for biosimilars does not require the performance of clinical trials across all approved indications of the reference drug; with approval, a biosimilar drug may have labeling that is identical to that of the reference product across multiple indications. Thus, as noted by the authors, clinician appraisal of and confidence in biosimilars will initially depend less on large clinical trials than on preclinical and pharmacologic data establishing bioequivalence and on their own clinical experience. In the absence of data from large clinical trial programs, there is also uncertainty regarding how biosimilars can be integrated into evidence-based clinical practice guidelines
Innovator biologics have no doubt proven efficacy, safety and have contributed to several unmet medical needs, however high costs and affordability of these drugs cannot be discounted. As the patents and exclusivity for many biologics are expiring, this has created the huge opportunity for the development and approval of biosimilars for many biopharmaceutical players including innovator generics and biotech companies. The Global Biosimilars market is expected grow at 23 % CAGR over 2017-2023, from USD 4.10 Billion in 2017 to USD 14.23 billion by 2023.
The emerging biosimilar products are recombinant blood products, therapeutic proteins, vaccines, growth hormones, biosimilar peptides, therapeutic proteins, monoclonal antibodies (mAbs) etc. Biosimilar insulins are the most expected ones in the class to enter the biosimilar landscape as patents for major branded insulin products start to expire in the next few years.
The current role of the pharmaceutical industry’s sales and marketing workforce will be replaced by a new model as the industry shifts from a mass-market to a target-market approach to increase revenue. Global pharmaceutical markets are in the midst of major discontinuities. While growth in developed markets will slow down, emerging markets will become increasingly important in the coming decade. The Indian pharmaceuticals market, along with the markets of China, Brazil and Russia, will spearhead growth within these markets.
Biopharmaceuticals are produced in living cells. They consist of human proteins, such as antibodies, hormones and cytokines, fragments thereof and other substances. The large majority of biologicals are produced in special cells, which are genetically modified and grown in special fermentors. Biotherapeutics differ in many ways from conventional (chemically produced) medicines, for example in manufacturing techniques, molecular size and complexity, stability of molecules and clinical properties.
Biotechnology is any technology that’s based on biology. Products that use living systems and organisms qualify as biotechnology. For thousands of years, the earliest farmers produced food and bred crops by utilizing a form of biotechnology.
Biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. Also called molecular marker and signature molecule
Biobetters are new molecular entities that are related to existing biologics by target or action, but they are deliberately altered to improve disposition, safety, efficacy, or manufacturing attributes
The pharma Pricing and Market Access (PPMA) work assumes a basic job all through a medication's lifecycle. During clinical improvement, PPMA input is urgent for organizing drugs which convey the most noteworthy worth and for molding clinical preliminaries dependent on payer necessities. From early advancement to past loss of selectiveness, the PPMA work underpins ideal valuing and market get to which establish the framework for persistent access and business achievement. A flurry of policy proposals, new regulations and investigations into biopharmaceutical drug pricing practices are changing the way medicines are bought and sold around the world.
Biologics or biological products are medicines made from living organisms through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics include a wide variety of products such as gene and cell therapies, therapeutic proteins, monoclonal antibodies, and vaccines. Biologics are used to prevent, treat or cure a variety of diseases including cancer, chronic kidney disease, diabetes, cystic fibrosis, and autoimmune disorders.
A biosimilar is exactly what its name implies — it is a biologic that is “similar” to another biologic medicine (known as a reference product) which is already licensed by the U.S. Food and Drug Administration (FDA).
This track discuses about the generic drugs impact on global biosimilar market, Cost and risk management, Adopting innovative mechanisms such as risk-sharing arrangement, European market for biosimilars. The global market scenario with the launch of first biosimilar in the market forecasts some radical changes. This track will look upon such key concerns which are witnessed by the global pharma market and that are coming up with the subsequent launch of the other biosimilars and biologics. Despite these emerging facilities, biotherapeutic developers are most comfortable off-shoring to established markets—the US and Europe.
Biosimilars are not the same as generic therapies. The term “generic” has a precise meaning when it comes to medications – it is limited to small-molecule medications made from synthesized chemicals with a fixed number of atoms and a known chemical structure. A generic must be chemically identical to its branded counterpart and contain the same active ingredients. Biosimilars are much larger molecules derived from living cells, making them challenging to develop and manufacture. A biosimilar also must demonstrate no clinically meaningful differences in efficacy, safety, and potency with its reference product
The BPCIA established a licensure pathway for competing versions of previously marketed biologics. In particular, the legislation established a licensure pathway for competing versions of previously marketed biologics. In particular, the legislation established a regulatory regime for two sorts of follow-on biologics,termed ”biosimilar” and “interchangeable” biologics. The Food and Drug Administration (FDA) was afforded a prominent role in determining the particular standards for biosimilarity and interchangeability for individual products.
Finally BPCIA created a patent dispute resolution procedure for use by brand- name and follow-on biologic manufacturers
Drug discovery is an inventive process of Medication discovered by biological target which involves the interaction of various disciplines leading to the invention of potent drug entities. The drug is most activates and inhibits the function of a biomolecule which in turn results in a therapeutic benefit to the patient. The process involves various branches of pharmacology coalesce with biotechnology, bioinformatics, molecular biology, nanotechnology and biochemistry that ultimately leads to the production of molecules of therapeutic value.
The first anticancer biosimilars have entered clinical use, with many others under clinical development. Like all biologics, biosimilars may elicit unwanted immune responses that can significantly impact clinical efficacy and safety. Head-to-head immunogenicity assessment of biosimilars and their reference biologics should, therefore, be a critical component of a biosimilar's clinical development program. Various bioanalytical platforms may be used to detect and characterize immune responses, each having relative strengths and weaknesses. To fully recognize the clinical relevance of such data, regulators must be able to interpret immunogenicity results in an assay-specific context as well as in perspective of clinical pharmacology, efficacy and safety
Bioavailability is referred to as the extent and rate to which the active drug ingredient or active moiety from the drug product is absorbed and becomes available at the site of drug action.
Bioequivalence studies conducted either during the development of the drug or after its marketing will be presented or discussed: Bioequivalence of highly variable drugs with the associated problem of widening the acceptance range or alternative solutions. Bioequivalence for investigating the food effect. Bioequivalence in special population such as children, non-Caucasian population. Bioequivalence based on in vitro data or literature. New approaches in bioequivalence interpretation. Bioequivalence and analytical methods which are not sensitive or specific enough.
It is well recognized that most licensed biologic products are covered by a multitude of patents. The biosimilars regime created a defined pathway to identify and litigate the patents covering a licensed product as part of a biosimilar challenge. The recent implementation of the America Invents Act provides further mechanisms to challenge patents outside of the courts. These mechanisms, notably an inter partes review or post grant review, have many advantages that should be understood by those contemplating or expecting a biosimilars challenge.
Regulatory efforts to formalize guidance policies on biosimilars, there remains a need to educate healthcare stakeholders on the acknowledged definition of biosimilarity and the data that underpin it. A number of biologics are fusion proteins in which the extracellular domain of a receptor has been fused with the Fc region of an immunoglobulin, usually a human IgG1, to generate a soluble form of the receptor. Etanercept is the best recognized example in rheumatologic practice because it is a soluble form of the p75 tumor necrosis factor (TNF) receptor that can bind and neutralize TNF Fusion proteins are relatively simple to design and can exploit the ligand redundancy of certain receptors, providing a broader specificity than antiligand or antireceptor mAbs.
Developing new biologics has led to regulations and norms aimed at guaranteeing their safety, quality and effectiveness, in terms of marketing, prescription, use, interchangeability and switching. Biologics are of great importance in treating patients suffering from rheumatic, autoimmune, inflammatory and neoplastic diseases. The expiry/lapse of reference biologics or originators' patents has meant that developing biosimilars involves accompanying legal requirements for their approval in countries worldwide. The main concept of this conference has thus approached the situation of biosimilar regulation worldwide, the pertinent technical concepts and regulatory differences in some countries of interest.
Biological medicines are far more structurally complex and very sensitive to manufacturing conditions and thus harder to characterize and produce than small molecule drugs. Even minor changes in manufacturing may cause significant variations of the cellular systems used for biological production, also on differences within the structure, stability, or other quality aspects of the top product, all of which have the potential to affect tolerability and/or efficacy and increase the danger of immune responses. Owing to these issues, specific regulatory guidance on biosimilars is continuously evolving, and there's some disagreement on which studies got to be implemented to approve a biosimilars.
Over the last 25 years many biological therapeutics have been approved for clinical use, and many of these for diseases where there was no other available therapy. There has been an evolution over this time period from proteins intended to be ‘nature identical’ to the development of engineered products and use of novel protein scaffolds intended to confer a pharmacokinetic, pharmacodynamic or other advantage over the natural counterpart. In addition, protein engineering has allowed the development of monoclonal antibodies as highly potent modulators directed at specific peptides/proteins.
This work was to suggest the biowaiver potential of biopharmaceutical classification system (BCS) Class II drugs in self-microemulsifying drug delivery systems (SMEDDS) which are known to increase the solubility, dissolution and oral absorption of water-insoluble drugs. Cyclosporine was selected as a representative BCS Class II drug. New generic candidate of cyclosporine SMEDDS (test) was applied for the study with brand SMEDDS (reference I) and cyclosporine self-emulsifying drug delivery systems (SEDDS, reference II). Solubility and dissolution of cyclosporine from SMEDDS were critically enhanced, which were the similar behaviors with BCS class I drug
Cancer therapy has evolved significantly with increased adoption of biologic agents. When the patent on the cancer drug trastuzumab (Herceptin) expires next year, patients who have been receiving this biological therapy will have another treatment option: a biosimilar drug—a drug that is very similar, but not identical, to trastuzumab. The escalating cost of cancer care is placing an increasing burden on healthcare systems worldwide, largely a result of expensive biologic therapies
Biotherapeutic agents, also known as biologics, are large complex molecules that are produced in living systems. Biologics comprise a range of molecules with varying complexities, including peptides, such as human insulin; small proteins, like erythropoietin; and large molecules, including monoclonal antibodies.2 The use of biologics in the field of gastroenterology is largely confined to the treatment of the immune-mediated inflammatory bowel diseases (IBD), such as ulcerative colitis (UC) and Crohn’s disease (CD)
The treatment of rheumatic diseases have acknowledged that biosimilars and biologic DMARDs (bDMARDs) are interchangeable in clinical practice, except when patients experience lack of efficacy or tolerability with the reference agent. Given that cost is a barrier to effective bDMARD use, the introduction of less costly biosimilars is likely to widen access and dissipate treatment inequalities. Physicians faced with prescribing decisions should be reassured by the robust and exhaustive process that is involved in assuring comparability of biosimilars with their reference agents. De novo usage of a biosimilar and switching to a biosimilar following lack of efficacy or tolerability with a different reference biologic agent are likely to be strategies most easily adopted, although switching during successful treatment should also be considered given the potential cost implications.
There is no cure for inflammatory bowel disease (IBD), its symptoms can be treated and remission induced using biological medicines, including the anti-TNF (tumour necrosis factor) drug infliximab. Biosimilars of infliximab have been made available in guidelines from the British Society of Gastroenterology and the National Institute for Health and Care Excellence, and they represent a considerable cost-saving opportunity for the NHS. The potential difficulties of switching infliximab to a biosimilar at a hospital can be overcome with a two-step implementation process