PubMed Journals Articles About "Zydus Spies Opportunities Brazil Mexico Along With Biosimilars"

Biosimilars: The 'future' of biologic therapy?

Abstract The introduction of a number of biologic therapies to the market has revolutionized therapeutics in dermatology. However, the patents protecting their manufacture are about to lapse, and follow-on generic products, known as biosimilars, are about to flood the pharmaceutical market. The 'biosimilars' are different from the generic products of conventional drugs in terms of efficacy, safety and immunogenicity. This awareness is essential for their proper prescription and the safety of patients. This...

Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars.

Biologics such as monoclonal antibodies are much more complex than small-molecule drugs, which raises challenging questions for the development and regulatory evaluation of follow-on versions of such biopharmaceutical products (also known as biosimilars) and their clinical use once patent protection for the pioneering biologic has expired. With the recent introduction of regulatory pathways for follow-on versions of complex biologics, the role of analytical technologies in comparing biosimilars with the cor...

Biosimilars and market access: a question of comparability and costs?

This article discusses specific issues related to the market access of biosimilars. Biopharmaceuticals are complex molecules produced by living cells. Copies of these medicines, called biosimilars, are not identical to their reference medicine and therefore specific regulatory requirements apply. When considering the use of biosimilars, the question of the degree of comparability between a biosimilar and the reference biopharmaceutical needs to be considered for registration, pricing and reimbursement purpo...

The spies above your backyard.

The spies who sabotaged global health.

Intussusception risk and health benefits of rotavirus vaccination in Mexico and Brazil.

Because postlicensure surveillance determined that a previous rotavirus vaccine, RotaShield, caused intussusception in 1 of every 10,000 recipients, we assessed the association of the new monovalent rotavirus vaccine (RV1) with intussusception after routine immunization of infants in Mexico and Brazil.

What do prescribers think of biosimilars?

Until recently, prescribers had to deal with generics, considered to be simple molecules that are easy to copy. But as discussed in this paper, the biodisponibility of generics remains a source of uncertainty. And now there are biosimilars, limited for the time being in the cancer setting to granulocyte-colony stimulating factors (G-CSFs) and epoetins. Soon there will be biosimilar monoclonal antibodies with anticancer activity. Prescribers will ask, as they did for generics, if such drugs have the same act...

Pharmacovigilance and biosimilars: considerations, needs and challenges.

Introduction: Biosimilars are biologic medicines that are highly similar to approved biologics, notwithstanding minor differences in clinically inactive components. Since 2007, biosimilars have been approved for use in patients in the European Union (EU) and other regions. European experience provides several lessons as the United States (US) healthcare system prepares for biosimilar approvals. These lessons emphasize the need for adequate efficacy and safety studies, post-marketing surveys and a robust pha...

The wisdom of psychopaths: what saints, spies, and serial killers can teach us about success.

Biosimilars and Regulatory Authorities.

The patent expirations for many biotechnological medicines have prompted the development of copies of biological medicinal products. Unlike generics, biosimilars are similar but not identical to their reference product, because their chemical characteristics are directly related to the manufacturing process which cannot be precisely duplicated. The regulatory policy for biosimilars is complex and in Europe it is regulated mainly by guidelines issued by the European Medicines Agency (EMEA); additional produc...

Development and Regulation of Biosimilars: Current Status and Future Challenges.

Biologic medicinal products developed via rDNA technology as recombinant protein-based medicines that have been in clinical use since the early 1980s as original biopharmaceuticals have greatly contributed to the therapy of severe metabolic and degenerative diseases. The recent expiration of the data protection or patents for most of them created opportunities for the development of copy versions of original biopharmaceuticals with similar biologic activity (termed biosimilars). Production of these new prod...

Risk management of biosimilars in oncology: each medicine is a work in progress.

Drug licensing and drug safety monitoring for standard chemical entities have been established and are routinely used. These have resulted in a solid foundation of knowledge from which confident therapeutic decisions can be made. For many chemical entities, this advanced level of experience is also present for the generic products. The expertise surrounding the development of biosimilar competitor versions is increasing and progress is encouraging. To address the re-engineering and comparability complexitie...

Reply to 'Comment on "A systematic review of the efficacy of globus pallidus stimulation in the treatment of Parkinson's disease"'

Biosimilar rhG-CSFs: how similar are they?

Biosimilars are more affordable copycat versions of originator biological products in much the same way as generics are copies of small molecule pharmaceuticals. However, while generics are approved on the basis of structural and pharmacokinetic equivalence, the intricate structure of biological medicinal products and the complex nature of their manufacturing process in living organisms impose a separate, and more stringent, regulatory approval process. The aims of this article are (a) to discuss key aspect...

Addressing the health technology assessment of biosimilar pharmaceuticals.

Abstract The growing number of biosimilars presents challenges to regulatory and health technology assessment (HTA) systems. This paper illustrates these challenges by focusing on biosimilars used in the oncological setting. In particular, discordances between data required by regulatory and HTA authorities potentially deprive patients of effective treatments and hinder optimal resource allocation. Regulatory and HTA authorities need to harmonize requirements to foster the development and widespread use of...

Planetary science. Cassini spies an ocean inside Saturn's icy, gassy moon Titan.

Evidence of two genetic clusters of manatees with low genetic diversity in Mexico and implications for their conservation.

The Antillean manatee (Trichechus manatus manatus) occupies the tropical coastal waters of the Greater Antilles and Caribbean, extending from Mexico along Central and South America to Brazil. Historically, manatees were abundant in Mexico, but hunting during the pre-Columbian period, the Spanish colonization and throughout the history of Mexico, has resulted in the significantly reduced population occupying Mexico today. The genetic structure, using microsatellites, shows the presence of two populations in...

Memoranda: History of the teaching of Biochemistry in Mexico.

Colony stimulating factors (CSF) biosimilars. Progress?

Biosimilars are equivalent drugs for other biotechnological drugs for which patent has expired. These biopharmaceuticals are often looked upon as simple copies of parent drugs whose goal is solely to potentially generate costs savings. The expansion of available drugs is a subject of attention, criticism and quarrels, often related to a lack of product knowledge. These drugs are copies but need scientific development that must meet many strict rules. Many questions arise in connection with the marketing of...

Childhood Diarrhea Deaths after Rotavirus Vaccination in Mexico.

Rotavirus is associated with substantial global mortality and morbidity. The use of the rotavirus vaccine is associated with a sustained decrease in the rate of death related to childhood diarrhea in Mexico.

Genetic diversity of Histoplasma capsulatum isolated from infected bats randomly captured in Mexico, Brazil, and Argentina, using the polymorphism of (GA)(n) microsatellite and its flanking regions.

The genetic diversity of 47 Histoplasma capsulatum isolates from infected bats captured in Mexico, Brazil, and Argentina was studied, using sequence polymorphism of a 240-nucleotides (nt) fragment, which includes the (GA)(n) length microsatellite and its flanking regions within the HSP60 gene. Three human clinical strains were used as geographic references. Based on phylogenetic analyses of 240-nt fragments achieved, the relationships among H. capsulatum isolates were resolved using neighbour-joining and ma...

Erythropoietin biosimilars currently available in hematology-oncology.

The discovery of epoietin (EPO) and the cloning of its gene facilitated the understanding of the mechanism of control behind red blood cell formation. This cloning was followed by the commercial development of recombinant human EPO (rHuEPO). The use of erythropoiesis-stimulating agents (ESAs) (epoietin, ESA, EPO) is important for the treatment of anemia in patients with chronic renal failure and cancer patients with chemotherapy-induced anemia. After several years of discussions, debates and questions, ESA,...

Erratum to: QTL for yield and associated traits in the Seri/Babax population grown across several environments in Mexico, in the West Asia, North Africa, and South Asia regions.

Vasculitis: report from Mexico.

Although primary sytemic vasculitides (PSV) are infrequent diseases, basic and clinical research have increased the knowledge of these autoimmune conditions substantially. Some PSV seem to be more frequent in certain countries. Here we present a brief history of the modest but important contributions made by Mexico to this area of research.

Biosimilars in rheumatology: a view from Latin America.