Biosimilar Research Articles

Biogenerics and biobetters v/s chemical based drugs - comparative discourse

Biogenerics and biobetters v/s chemical based drugs - comparative discourse

PHP19 - Management of Biosimilars: Key Considerations for Pharmacists in Patient Care

The US market for Biosimilars (BS) is expanding. The inherent differences in living systems contribute to the complexity of replicating the biologics and manufacturing BS. Pharmacists being one of the first healthcare providers that the patients approach for drug related issues, it is essential for them to be aware of BS management. The goal of this project is to serve as a primer to the process of discovering the role of pharmacists in the management of safety and efficacy problems associated with BS. This project explores and summarizes the key considerations for the pharmacists for better management of BS in their everyday practice. A systematic and comprehensive review of literature from EBSCO, ScienceDirect, ProQuest Direct, and Pub Med was conducted. Information from relevant articles and studies published between 2009--present was selected. Articles were grouped according to three areas of focus: formulary management, pharmacy substitution laws, and medication non-adherence issues. A narrative analysis was used to synthesize the results. The review identified twenty eligible full-text articles. To substitute biologics for less expensive BS, the pharmacists have to abide by the interchangeability provisions of FDA and be aware of legal parameters related to informing the prescriber and maintaining records. To evaluate the inclusion of a BS in the formulary, the pharmacists need to evaluate the safety and efficacy, manufacturer considerations, and hospital and patient considerations. Moreover, having an understanding of the factors that affect patient adherence will help pharmacists promote adherence and prevent adverse drug events. To ensure the proper use and minimize risks associated with BS, pharmacists’ understanding and knowledge of the substitution laws, formulary management, and adherence concerns are necessary. These criteria can serve as the base for optimal outcomes, but the final approach to care needs to be customized on individual product and patient basis.

PHP99 - An International Comparison of Antineoplastic and Imunomodulating Agent Price in Thirteen Countries : Patented Medicines, Chemical Entities, and Biologics

Global oncology drug costs are likely to keep growing and reaching an estimated 178 billion dollars in 2020.This study aims to compare price of eighty molecules of antineoplastic and immune-modulating medicines in 2016. We calculated the average price per dose by dividing the total sales across molecule by patent status medicines, chemical entities, and biologics, using IMS data on ex-manufacturer prices of medicines of common eighty molecules in antineoplastic and immunomodulating agent area in thirteen high-income countries (US, Japan, Germany, France, Italy, UK, Spain, Australia, South Korea, Switzerland, Taiwan, Sweden, and Austria) In price comparison of patent protected 14 biologics and 35 chemical entities, US ranks the first position (2,624$US and, 376$US, respectively) and the price was almost as twice as that of the 2nd place, Switzerland (1,463$US and 172$US, respectively). We compared the price of biologics/chemical entities based on original status vs their counterparts, it showed that the US ranked first again in follow-on biologics and the price of branded biologics was about 6 times that of follow-on biologics. Biggest difference was observed in Italy, where and the price of branded biologics was about 11 times that of follow-on biologics. The smallest difference was found in South Korea (4.3 times), where the price of follow-on biologics was higher than average and branded biologics was the lowest. Regarding chemical drugs, the biggest difference between original and generic was observed in Sweden (6 times), and the smallest in France (0.9). The results show that US ranked the highest price in all three comparisons among thirteen countries and the price difference between branded vs. generics varied greatly. The price level of generics (follow-ons) was not in line with that of branded drugs, which might be associated with various country-specific policies.

Biosimilars: same ol’ – but with a suffix, and cheaper

Biosimilars: same ol’ – but with a suffix, and cheaper

A Guide to Follow-on Biologics and Biosimilars with a Focus on Insulin

Many healthcare providers in the U.S. are not familiar with follow-on biologics and biosimilars nor with their critical distinctions from standard generics. Our aim is to provide a detailed review of both, with a focus on insulins in the U.S. regulatory system. Literature has been reviewed to provide information on various aspects of biosimilars and a follow-on biologic of insulin. This will include structure, efficacy, cost, switching, and legal issues. Biologic products are large, complex molecules derived from living sources. Follow-on biologics are copies of the original innovator biologics. It is not possible to copy their structure exactly, leading to possible differences in efficacy and safety. Thus, regulations involving biologics are complex. Follow-on biologics are regulated under two Federal laws until March 23, 2020: the Public Health Service Act (PHS Act) and the Federal Food, Drug, and Cosmetic Act. Biosimilars are follow-on biologics which have been approved via the PHS Act. They consist of those which are "highly similar" to the reference drug and those which are "expected" to produce the same clinical result as the reference drug (interchangeable biosimilars). Interchangeable biosimilars have been determined by the U.S. Food and Drug Administration to be substitutable by the pharmacist "without the intervention" of the prescriber. From the patient perspective, switching to a follow-on biologic may necessitate a change in delivery device, which may create issues for patient adherence and dosing. Although they present several challenges in terms of regulation and acceptance, follow-on biologics have the potential to significantly reduce costs for patients requiring insulin therapy. BLA = biologics license application EU = European Union FDA = Food and Drug Administration FD&C = Food, Drug, and Cosmetic HCPCS = Healthcare Common Procedure Coding System INN = internatinal nonproprietary name NDA = new drug application PHS = Public Health Service.

Diagnosis and treatment of rheumatoid arthritis:toward the best practice. The best practice for TNF inhibitors.

As of February 2018, 5 originator TNF inhibitors(infliximab, etanercept, adalimumab, golimumab and certolizumab pegol)and biosimilar agents of infliximab and etanercept are available for rheumatoid arthritis(RA)in Japan. The effectiveness of TNF inhibitors considerably improves with concomitant methotrexate regardless of their immunogenicity. The Japan College of Rheumatology guideline for TNF inhibitor use in RA has been updated in March 2017 according to recent evidences. During the remission induction phase, maintenance of drug trough level above effective blood concentration is paramount, while the tapering and withdrawal of TNF inhibitors may be considered after achieving sustained remission.

Biosimilar Trastuzumab for HER2-Positive Breast Cancer

The promise of biosimilar therapeutic and supportive agents in oncology offers the possibility of less expensive drugs that are equivalent in efficacy

New framework helps NHS realise the potential of biosimilars

New framework helps NHS realise the potential of biosimilars

Quality characteristics and nonclinical/clinical profiles of Etanercept BS SC [MA]

Etanercept is a dimeric genetic recombinant glycoprotein consisting of Fc domain of human Immunoglobulin G1 and the extracellular domain of human tumor necrosis factor (TNF) receptor type II. Etanercept exerts therapeutic effects on inflammatory diseases such as rheumatoid arthritis and juvenile idiopathic arthritis by neutralizing biological activities of TNFα/Lymphotoxin (LT) α. Mochida Pharmaceutical and LG Chem have developed syringe, pen, and vial products of Etanercept BS (biosimilar) as the first biosimilar of Enbrel in Japan. The active ingredient of those products "Etanercept biosimilar 1" has the identical primary structure to that of Enbrel. The development of the Etanercept BS, including evaluations of quality attributes, nonclinical and clinical studies was performed in accordance with "Policies on Assurance of Quality, Safety and Efficacy of Biosimilars". The quality attributes of Etanercept BS were similar to those of Enbrel, and the binding affinities to TNFα/LTα, TNFα neutralizing activity, nonclinical pharmacokinetics and toxicological profiles of Etanercept BS were comparable to Enbrel. Additionally, the pharmacokinetic profile and efficacy of Etanercept BS were equivalent to those of Enbrel and there was no clinically significant difference in safety profiles between them in Phase I and Phase III clinical studies. The marketing approval application of the Etanercept BS with the same indications as Enbrel filed by Mochida Pharmaceutical was approved in January 2018 and the products will be launched by Ayumi Pharmaceutical in the near future. The Etanercept BS, which is as highly effective as Enbrel is expected to make beneficial therapies more easily accessible to patients.

Ten things pharmacists should know about biologics and biosimilars

Ten things pharmacists should know about biologics and biosimilars

The Disappointment of the Biosimilar.

The Disappointment of the Biosimilar.

In-depth look at biologics and biosimilars

In-depth look at biologics and biosimilars

Biosimilars: Why are they so widely misunderstood?

Biosimilars: Why are they so widely misunderstood?

INSIDE INDUSTRY

Drug development companies in APAC need to raise their game to capitalise on the $33bn+ immuno-oncology treatment opportunity Singapore’s pharmaceutical market value to reach $1.15 billion by 2021 Ryzodeg reduces hypoglycaemia in type 2 diabetic fasting patients FDA approves Amgen’s Repatha (evolocumab) to prevent heart attack and stroke FDA approves first drug for rare disease, eosinophilic granulomatosis with polyangiitis FDA approves first biosimilar for the treatment of certain breast and stomach cancers FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss Singapore institutes collaborate with Samsung Medical Center to improve treatment of liver cancer Globavir announces partnership with Singhealth Duke-NUS Academic Medical Centre to study dengue treatment Mundipharma secures exclusive license for the development and commercialisation of PAION’s remimazolam in Japan

Preclinical Safety Considerations for Biosimilars

It is now a foregone conclusion that the new frontier of biomedical research lies in biologics, which hold the potential to yield, over time, effective treatments for conditions or diseases hitherto considered incurable or untreatable. On the scale of medical development, biologics are a fairly recent innovation and the majority of them are still under patent protection. The global outlook for biologics is positive and it is estimated that approximately two-dozen biological products with global sales of more than $67 billion will come off patent by 2020. Advances in biotechnology and the end of patent exclusivity have resulted in burgeoning opportunities for cost-effective followon biologics, commonly known as ‘biosimilars’, to enter the market. Unlike generic chemical drugs, biosimilars are similar but not identical to their respective reference innovator products. Even minor changes to the original manufacturing process may result in alterations to the secondary, tertiary, and quaternary structure of the molecule, which may have an impact on the efficacy and safety of the drug in various therapeutic indications and its safety profile in diverse risk populations may be different from that of the innovator product. The assessment of toxicity and safety of monoclonal antibodies (mAbs) becomes more challenging because of the higher complexity and size of these products, giving rise to higher variability. The manufacturing of biosimilar mAbs can lead to differences in glycosylation pattern, resulting in a high level of micro-heterogeneity. In addition, mAbs often have a complex mode of action as they comprise multifunctional molecules with biological properties involving both their Fab and Fc fragments. Many challenges are associated with the approval process of biosimilar mAbs. Read More...

Biosimilar medicines and patient registries – expectations, limitations, and opportunities

Abstract Introduction: Biology therapies in a various medical specializations and for a broad spectrum of indications were launched during last two decades. As a new in class the therapies were obliged to provide additional data re gar ding efficacy and safety after their real medical practice integration. Patient registries, databases collecting various patient data, were introduced to grant data on the treatment effectiveness, safety, and long-term on treatment survival. Satisfactory treatment effect and acceptable safety profile were confirmed after couple of years of careful observation. However, the benefits were usually offered at much higher treatment costs compared to the standard therapies. Biologically similar drugs, so-called biosimilars (B.S), are being launched after original molecule patent protection expiry during recent years. They were expected as an ideal solution to avoid distinct impact on the medical budget: comparable effect for less money. The unsubstantiated doubts about biosimilar efficacy and safety were the reason of the late launch in many markets. Since biosimilars are considered as new therapy entities, the cautiousness to certain extent should be required. Information gained from post-marketing observations and patient registries over several years, confirmed the biosimilar product comparable quality. Healthcare budget savings could secure easier therapy access for more new patients.

FDA approves Ogivri as a biosimilar to Herceptin

FDA approves Ogivri as a biosimilar to Herceptin

Aace/ace Position Statement on the use of follow-on Biologics and Biosimilars for Endocrine Diseases

BPCIA = Biologics Price Competition and Innovation Act; FDA = Food and Drug Administration; FFDC = Federal Food Drug and Cosmetics Act; PHS = Public Health Services Act; TE = therapeutic equivalence.

A Randomized, Double-Blind, Multicenter Study to Compare the Efficacy, Safety, and Immunogenicity of a Proposed Adalimumab Biosimilar (GP2017) with Originator Adalimumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis

Abstract Not Available

How similar is biosimilar

How similar is biosimilar