Search results for Opinion

Preserve the US interchangeable standard that has helped drive physician and patient confidence in biosimilars

Abstract: The US Food and Drug Administration (FDA) proposed eliminating the distinction between biosimilars and interchangeable biosimilars with the stated aim of aligning with European policy and enhance biosimilar uptake. However, this move is misguided as it would result in widespread generic-style automatic substitution at the pharmacy level; which is rare in Europe. Physician confidence […]

Read more →

Biosimilars drug development: time for a paradigm shift?

Author byline as per print journal: Sandeep N Athalye, MBBS, MD; Shivani Mittra, MPharm, PhD; Ankitkumar M Ranpura, MD Abstract: The sky-rocketing cost of developing biosimilars is becoming a shared deterrent for biosimilar developers. The regulatory requirements for biosimilars must see a natural evolution and a paradigm shift towards removing inefficiencies in clinical designs to […]

Read more →

Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance

Abstract: Current regulations do not require a given biosimilar to remain similar to its reference biological over time. However, two products that were initially deemed biosimilar or interchangeable could each undergo unique patterns of drift and evolution in their manufacturing processes (divergence), ultimately resulting in two products that would be no longer biosimilar. In cases […]

Read more →

Why ‘similar’ can make a big difference

Abstract: This article explains what motivated the Digestive Cancers Europe’s (DiCE) recent position paper on biosimilar medicines for colorectal cancer. Submitted: 7 October 2019; Revised: 14 October 2019; Accepted: 15 October 2019; Published online first: 25 October 2019 Background Colorectal cancer may not be as widely known or talked about as some other types of […]

Read more →

Rationalizing FDA guidance on biosimilars—expediting approvals and acceptance

Abstract: Biosimilar drugs have suffered slow entrance and acceptance rates in the US market, due not only to common misperceptions among the public but also US Food and Drug Administration (FDA) licensing laws. This review offers nine major recommendations for the FDA to simplify how biosimilars are licensed and thus make biosimilars more accessible to […]

Read more →

Austrian medicines authority positive towards biosimilar interchangeability

Abstract: Clinical evidence supporting biosimilar use is growing and for the first time, the Austrian Medicines and Medical Devices Agency takes a positive position on interchangeability. They now state that prescribing biosimilars to treatment-naïve patients and even a change from originator to biosimilar is appropriate, provided it is done under physician’s supervision. Submitted: 9 January […]

Read more →

Where does the value of ‘value-added’ pharmaceuticals come from?

Abstract: The role of sound science, discovery, and innovation in value-added pharmaceuticals has not been sufficiently considered. This term is mainly used to define improved version of generic drugs. The concept of value-added pharmaceuticals has been picked up by different groups of companies, some are aiming to increase willingness to pay for their modified pharmaceutical […]

Read more →

Overview of non-innovator biological products in India

Abstract: As per regulatory requirements, biosimilar drugs must show high similarity to their reference product in quality, preclinical and clinical tests. It is by these means that biosimilars are considered to be safe and efficacious. In India, any major deviation(s) from science-based principles in the manufacturing of a recombinant DNA-derived therapeutic biological product leads to […]

Read more →

Challenges of developing generics substitution policies in low- and middle-income countries (LMICs)

Abstract: There are few challenges to developing effective generics substitution policies in low- and middle-income countries (LMICs). These include the absence of generics substitution policies, lack of enforcement, lack of evidenced-based data about bioequivalence and lack of acceptance by physicians and patients. Submitted: 3 June 2015; Revised: 19 June 2015; Accepted: 24 June 2015; Published […]

Read more →

Is Australia positioned to take advantage of biosimilars?

Abstract: Australia currently has a small generic and biosimilar medicine industry despite having a good track record in biomedical research and a sound reputation in producing high quality but small volume biological pharmaceuticals. In recent times, Australia has made incremental changes to its regulation of biosimilars – in patent registration, in the use of commercial […]

Read more →

Tell me the whole story: the role of product labelling in building user confidence in biosimilars in Europe

Abstract: The European Medicines Agency (EMA) has led the development of biosimilar regulatory pathways globally, tailoring their approach to meet the specific and scientifically determined needs of biosimilar development. However, the information-driven stepwise approach encouraged by this pathway leading to approval of biosimilar products is only reflected in a single section of the product labelling […]

Read more →

Pathway to affordable, quality-assured sources of pegylated interferon alpha for treating hepatitis C

Author byline as per print journal: Barbara Milan, Sara Gaspani Introduction: The current pipeline of promising oral hepatitis C drugs could lead to a revolution in treatment for this disease in both developed and developing countries. At present, the recommended treatment is pegylated interferon alpha (in combination with ribavirin). However, the limited availability and high […]

Read more →