Biosimilars

Merck acquires follow-on Copaxone NBCD: determined to lead in MS

Biosimilars/General | Posted 10/11/2011

Germany-based Merck already markets its own multiple sclerosis (MS) drug Rebif (interferon beta-1a) but suffered a major blow during 2011 when regulators on both sides of the Atlantic rejected its oral MS treatment Movectro (cladribine). Merck has since abandoned the project.

Can biosimilar manufacturers learn from generic substitution issues

Biosimilars/Research | Posted 04/11/2011

The substitution of generic prescription medicines for branded medicines is practiced in most Westernised countries, mainly because of its clear economic benefits. Patient experiences of generic substitution are mixed however, with many patients left confused or suspicious [1]. Given that a number of second-generation biosimilar compounds are expected to be approved within the next few years, and that biosimilar manufacturing costs are much higher than those of a simple generic, it is crucial for biosimilar manufacturers to avoid the uncertainty and mistrust that often accompanies generic substitution. Several recommendations have been made to help ensure that substitution pathways are streamlined and successful [1] but can any of these recommendations be applied to biosimilars?

US biosimilars: a report on FDA progress

Biosimilars/Research | Posted 04/11/2011

This article reviews the steps being taken by FDA to implement the Biologics Price Competition and Innovation (BPCI) Act of 2009, enshrined in law in 2010 as the ‘biosimilars statute’.

US$1 billion for cancer R & D

Biosimilars/News | Posted 04/11/2011

GE Healthcare, the health business of General Electric, provides advanced cancer diagnostic and molecular imaging capabilities, as well as technologies for the manufacture of biopharmaceuticals and for cancer research. Its presence at the European Multidisciplinary Cancer Congress 2011 in Stockholm indicated its commitment to strengthening cancer diagnosis and care. Similarly at the 53rd Annual American Society for Radiation Oncology Meeting in Miami Beach, Florida, USA, it was showcasing a number of new tools designed specifically for the needs of radiation oncologists.

Development of biosimilars is not an easy matter

Biosimilars/Research | Posted 28/10/2011

By 2020 biological products with sales of around US$23 billion in the EU and US$29 billion in the US will be exposed to biosimilar competition [1]. As more and more biologicals lose their patent protection, it is no wonder that Big Pharma, the biotechnology industry and generics manufacturers, as well as regulatory agencies, are becoming increasingly interested in biosimilars [2].

Brand-name statins costing healthcare system US$6.7 billion

Biosimilars/Research | Posted 21/10/2011

Researchers at Mount Sinai School of Medicine, New York, USA, found that physicians prescribing unnecessary treatments or diagnostic tests, spanning a broad range of clinical conditions, costs the US healthcare system an extra US$6.7 billion annually. The findings, published in Archives of Internal Medicine, attributed prescribing of brand-name statins instead of generic statins as accounting for most of the excess cost [1].

Rituximab biosimilar successfully produced in plants

Biosimilars/News | Posted 21/10/2011

iBio, a leader in the plant-made pharmaceutical field, announced on 5 October 2011 that it had successfully expanded the use of its technology to biosimilar monoclonal antibodies (mAbs) by producing rituximab in non-transgenic green plants.

Biosimilar user fees proposal under review

Biosimilars/News | Posted 21/10/2011

Proposals over biosimilar user fees appear to have been ratified by stakeholders and a proposal is now under review by the US Department of Health and Human Services.

EMA definitions of generics and biosimilars

Biosimilars/General | Posted 21/10/2011

Confusion surrounding terms used in the global field of generics and biosimilars is a recognised problem. The members of the Biosimilar Medicinal Products Working Party at EMA have recently expressed the need to propose a more precise definition for biosimilars due to problems arising from imprecise usage of the term in the scientific literature and elsewhere [1].

Biocon announces Malaysia manufacturing plant

Biosimilars/News | Posted 21/10/2011

Biocon, a global biopharmaceutical company with high-tech manufacturing and research arms, announced in September 2011 ‘project commencement for its first high-end biopharmaceutical manufacturing and R & D facility in Bio-XCell, Malaysia’ [1]. Malaysia, epitomised by the Bio-XCell biotechnology park, is considered ‘an ideal location to manufacture generics’ by industry analysts Frost & Sullivan.

Cheap biosimilars to come from India and China

Biosimilars/News | Posted 21/10/2011

On 19-20 September 2011, the United Nations (UN) held a High-Level Meeting to develop a global strategy to fight non-communicable diseases, ‘principally cardiovascular diseases, cancers, chronic respiratory diseases and diabetes.’ It is only the second global health issue that the UN General Assembly has deemed urgent enough to call a meeting to discuss. Such diseases cause approximately two-thirds of all deaths.

Biotech pipeline and biosimilars

Biosimilars/Research | Posted 14/10/2011

There are more than 200 new biotechnology products in the pipeline (phase II to registered), all of which could be future targets for biosimilars. However, around 60% of these products concern mechanisms of action that are already available, see Figure 1 [1].

A snapshot of interesting new approvals by FDA

Biosimilars/News | Posted 14/10/2011

New approvals by FDA look set reach record levels in 2011. Some noteworthy drugs already approved in 2011 are discussed below.

Biosimilars or biobetters–what does the future hold

Biosimilars/Research | Posted 14/10/2011

Biosuperiors or biobetters are improvements to originator biological molecules, whereas biosimilars are structural imitations of the originator. But how will the pharma industry choose to pursue this lucrative market and benefit from patent expirations on biologicals? Will biobetters or biosimilars be the winners?

Biobetter of trastuzumab on the horizon

Biosimilars/General | Posted 14/10/2011

TrasGEX, which is currently under development by German biopharma company Glycotope, is shaping up to be an improved version (or biobetter) of Roche’s blockbuster cancer drug Herceptin (trastuzumab). Trastuzumab targets the HER2 receptor, commonly overexpressed in a variety of cancers, such as HER2-positive breast and stomach cancer.

EMA plans to revise biosimilar guidelines

Biosimilars/News | Posted 07/10/2011

EMA announced on 3 October 2011 that it has published a concept paper asking for comments on topics to be included in a potential revision of the agency’s 2006 biosimilar guideline, which covers non-clinical and clinical development of biosimilars. The paper will be released for a 3-month consultation period.

Biosimilar user fee levels and performance goals for the FDA

Biosimilars/News | Posted 07/10/2011

FDA and representatives from the drug industry negotiating a user fee for biosimilars have tentatively set performance goals and biosimilar user fee levels, creating a separate review programme for biosimilars.

How profitable will biosimilars be

Biosimilars/Research | Posted 07/10/2011

The profitability of biosimilars remains an open question. Five years after launch it is thought that most biosimilars markets will look similar to generics markets (70% penetration, 25% of brand-name drug price) but also that a ‘brand-like’ market with lower price attrition and market share is possible [1].

FDA new drug approvals up in 2011: 900 biotech drugs in development

Biosimilars/News | Posted 07/10/2011

FDA had already approved 26 new drugs by the end of August 2011 compared to only 21 approved in 2010. Of note were six cancer drugs and two ground-breaking drugs for hepatitis C. The current year looks likely set a record for recent years for new drug approvals, which may total 35–40 by the end of 2011. After a slow start in the first two months with three new drug approvals and nine rejections in January and February 2011, FDA approved four new drugs, two of which were monoclonal antibodies, in March and five in April. Of the 11 new drugs approved in the first four months, only three biologicals were approved.

US$54 billion worth of biosimilar patents expiring before 2020

Biosimilars/Research | Posted 30/09/2011

By 2020 biological products with sales of around US$23 billion in the EU and US$29 billion in the US are expected to be exposed to biosimilar competition [1].

Boehringer Ingelheim joins other Big Pharma going into biosimilars

Biosimilars/News | Posted 30/09/2011

Big Pharma is once again taking a major interest in biosimilars. The latest big pharmaceutical player to show an interest is biopharmaceutical specialist Boehringer Ingelheim. The German-based company announced on 26 September 2011 that it would create a dedicated division for the development and commercialisation of biosimilars.

Amphastar’s biosimilar enoxaparin approved by FDA – Momenta launches lawsuit

Biosimilars/News | Posted 30/09/2011

On 19 September 2011, and after years of conflict with FDA, Amphastar Pharmaceuticals (Amphastar) finally received approval to market a biosimilar version of sanofi-aventis’s blockbuster blood-thinner Lovenox (enoxaparin). The announcement, however, was closely followed by news that Momenta Pharmaceuticals (Momenta) had launched a lawsuit against Amphastar.

EMA biosimilar regulation should include complex biologicals

Biosimilars/Research | Posted 23/09/2011

The EMA’s comprehensive biosimilar regulatory pathway, which includes the need for new clinical trials and comparability studies that demonstrate quality, efficacy, and safety, should be expanded to include complex biologicals, according to innovation researchers at Utrecht University, Utrecht, The Netherlands [1].

Generics and biosimilars affected by Obama’s deficit plans

Biosimilars/News | Posted 23/09/2011

US President Barack Obama’s plan for economic growth and deficit reduction, announced on 19 September 2011, recommends a series of healthcare reforms. The proposals include higher drug rebates for low-income patients, banning pay-to-delay deals between generics and originator companies and reducing biologicals exclusivity from 12 to seven years. The proposals aim to save US$320 billion in healthcare spending over 10 years.

US biosimilars law may prove a barrier to entry for biosimilars

Biosimilars/Research | Posted 23/09/2011

One of the main barriers to biosimilar entry in the US is the US biosimilars law [1]. While some have questioned whether the biosimilars pathway in the US will ever be used [2, 3], others believe that, although flawed, the US biosimilars pathway is likely to become a functioning legal pathway [4].

The biosimilars landscape

Biosimilars/Research | Posted 23/09/2011

There is obviously a market for biosimilars. This is driven by the cost savings to be made by payers and patients alike. By 2015, IMS Health (IMS) expects spending on biosimilars to exceed US$2 billion annually, or about 1% of total global spending on biologicals. They expect new biosimilars to enter the US market by 2014 and European markets to have additional biosimilar molecules introduced during this period [1].

Sanofi announces new long-term objectives

Biosimilars/News | Posted 23/09/2011

At a ‘strategy and outlook’ seminar for investors held on 6 September 2011, sanofi-aventis (sanofi) CEO Mr Christopher A Viehbacher commented on the group’s outlook. The group has undergone radical changes since 2008, when it was faced with losing several blockbuster drugs over a relatively short time period, the so-called ‘patent cliff’. The main action sanofi took was to buy biotech company Genzyme and thus gain access to the biosimilars, rare diseases and multiple sclerosis markets. However, other actions not so interesting to the media have also played a great part in the company’s repositioning.

EMA comparability studies limiting biosimilar success

Biosimilars/Research | Posted 16/09/2011

The EMA’s comprehensive biosimilar regulatory pathway, which includes the need for new clinical trials and comparability studies that demonstrate quality, efficacy, and safety, is a barrier for the development of clinically superior compounds, according to innovation researchers at Utrecht University, Utrecht, The Netherlands [1].

Biosimilars: barriers to entry and profitability in the EU and US

Biosimilars/Research | Posted 16/09/2011

The implications of the US biosimilars law and the pending patent expiries of the 12 major biological products in the EU and the US will have an impact on the profitability and viability of the biosimilars industry [1].

The market for global and European biosimilars

Biosimilars/Research | Posted 16/09/2011

Due to expiring patents for brand name products, cheaper generics are expected to grab market share [1]. This is not surprising due to the list of blockbuster drugs losing their patent protection in 2011 and 2012. These include the world’s best-selling drug, Lipitor (atorvastatin), which in 2010 had almost US$13 billion in worldwide sales, accounting for 15.8% of Pfizer’s total revenue [2].

Hospira looks to biosimilars and increased use of generics for growth

Biosimilars/News | Posted 16/09/2011

Injectable generics leader, Hospira, announced on 7 September 2011 at its investor day, that it will look to biosimilars and international expansion for future growth.

Five years of bioequivalence data from Cetero questioned

Biosimilars/General | Posted 16/09/2011

FDA is challenging five years of bioequivalence and other studies conducted at Cetero Research’s Houston facility in the US. This could affect both originator and generics companies alike, putting into question data provided to FDA to support new drug applications (NDAs) and abbreviated new drug applications (ANDAs).

Biosimilars and the pharmaceutical industry

Biosimilars/Research | Posted 09/09/2011

IMS Health predicts a slowing down of the growth in annual spending on medicines, with generics being one of the main contributing factors for this reduction.

Positive results for phase I trial of biosimilar erythropoietin

Biosimilars/News | Posted 09/09/2011

Hospira, self-proclaimed leader in injectable generics, announced on 6 September 2011 positive results from a phase I clinical trial of its biosimilar erythropoietin (EPO) carried out in the US in patients with anaemia associated with chronic renal (kidney) failure and chemotherapy.

Opportunities for biosimilars in emerging markets

Biosimilars/Research | Posted 09/09/2011

By 2015, IMS Health expects spending on biosimilars to exceed US$2 billion annually, or about 1% of total global spending on biologicals [1]. This growth in biosimilars will be driven mainly by patent expiries coming in the next five years. However, due to the complexity and cost of developing biosimilars for western markets many biosimilar manufacturers are turning to emerging markets as being a much more cost-effective solution.

Biotech growth and biosimilar opportunities in India

Biosimilars/General | Posted 02/09/2011

The domestic biotechnology industry in India has seen rapid growth during 2010 and India is poised to attain a position of leadership in the biosimilars market according to reports from Ernst & Young India and Frost and Sullivan.

Doctors wary of using biosimilars for extrapolated indications

Biosimilars/Research | Posted 02/09/2011

A report published on 24 August 2011 by research and advisory firm Decision Resources finds that the majority of US and European physicians are wary of using a biosimilar for an indication for which supporting clinical data are lacking.

Stada and Richter to collaborate on biosimilar development

Biosimilars/News | Posted 02/09/2011

German generics giant Stada Arzneimittel (Stada) and Hungary-based Gedeon Richter (Richter) announced on 30 August 2011 that the two companies have signed licence and collaboration agreements for the development and marketing of two biosimilars.

Controversial nomenclature for new biosimilars

Biosimilars/Research | Posted 02/09/2011

How will FDA chose to name biosimilars? The answer it appears is not simple and could greatly affect the marketing costs associated with these products [1].

FDA and biosimilars: update on key themes

Biosimilars/General | Posted 26/08/2011

Since the existence of a legal pathway for biosimilars was made possible by the signing of the 2009 Biologics Price Competition and Innovation (BPCI) Act in 2010 by President Barack Obama, FDA has declared itself ‘open for business’ for biosimilars [1]. But what is the thinking of FDA and what should we expect from any guidance on biosimilars?