Biosimilars

Stada in-licenses teriparatide biosimilar

German generics giant Stada Arzneimittel (Stada) announced on 13 October 2014 that it had made a deal to in-licensing a teriparatide biosimilar.

Phase III study of biosimilar adalimumab meets primary endpoint

Biologicals major Amgen announced on 8 October 2014 the first late-stage data from its biosimilars programme. Primary efficacy analysis from a phase III trial of Amgen’s adalimumab biosimilar (ABP 501) compared with Humira (adalimumab) has demonstrated ‘clinical equivalence’.

Merck KGaA plans further investment in biosimilars

German pharma giant Merck KGaA announced on 18 September 2014 plans to step up investments in biosimilars during 2015.

Epirus and Livzon collaborate on copy biologicals for China

US-based Epirus Biopharmaceuticals (Epirus) announced on 25 September 2014 that it had signed a collaboration agreement with Chinese biotechnology company Livzon Mabpharm (Livzon).

Infliximab ‘similar biologic’ receives Indian approval

US-based biologicals company Epirus Biopharmaceuticals (Epirus) announced on 15 September 2014 that it had received final marketing and manufacturing approvals for its infliximab similar biologic, BOW015, from the Drug Controller General of India (DCGI).

Biosimilars of adalimumab

Last update: 11 March 2024

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

Mylan starts phase III trials for biosimilar insulin glargine

Generics maker Mylan has started two US phase III clinical trials for a biosimilar version of French drugmaker Sanofi’s diabetes drug Lantus (insulin glargine).

IAPO releases toolkit for biologicals and biosimilars

The International Alliance of Patients’ Organizations (IAPO), which comprises over 200 patient groups and represents the interests of patients worldwide, has published an Information and Advocacy Toolkit on Biological and Biosimilar Medicines for Patients’ Organizations. The Toolkit, published in November 2013, provides up-to-date, evidence-based information on the science, technology and regulatory information relevant to biologicals and biosimilars.

Call for action on labelling of biosimilars

European trade association, the European Association for Bioindustry (EuropaBio) has called on the European Medicines Agency (EMA) to define specific guidance on the labelling of biosimilars.

Amgen starts phase III trial for biosimilar rituximab

Biologicals major Amgen is carrying out a global phase III clinical trial for a biosimilar version of Roche’s blockbuster arthritis/non-Hodgkin’s lymphoma drug MabThera/Rituxan (rituximab).

Biosimilars applications under review by EMA – August 2014

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Roche updates position on biosimilars

Originator pharma company Roche has updated its position statement on biosimilars, stating that ‘biosimilars are not quite the same’.

Strategy for biosimilars in China

China is one of the largest pharmaceutical markets in the world, and has seen rapid growth in the biopharmaceuticals industry in recent years.  However, it is still lacking guidance when it comes to biosimilars. Authors Li and Tuan from the Shenyang Pharmaceutical University, China, discuss how this affects biologicals companies in China [1].

Biosimilars of trastuzumab

Last update: 15 January 2021

Trastuzumab is a monoclonal antibody that binds to and inactivates the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancers, HER2 is over-expressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat HER2 positive (HER2+) breast cancers.

Pegteograstim biological approved in South Korea

South Korean biologicals company, Green Cross, announced on 18 August 2014 that it had received marketing authorization from South Korea’s Ministry of Food and Drug Safety (MFDS) for its pegteograstim biological Neurapeg.

Patient access to rituximab in emerging markets

A Pfizer-sponsored study looking at access to the oncology treatment rituximab has revealed that use of this important drug would increase across all therapy types and markets if a biosimilar was available. A rituximab biosimilar would have the greatest impact in Brazil, Mexico and Russia.

Regulating the safety of biosimilars

Clinical safety is critically important during the development of a biosimilar. An overview of the main aspects of safety assessment of biosimilars has been prepared to assist all those interested in this area of growing importance [1].

FDA debuts purple book for biologicals and interchangeable biosimilars

On 9 September 2014, the US Food and Drug Administration (FDA) announced the publication of its first-ever edition of the ‘Purple Book’, a new set of lists of licensed biological products and interchangeable biosimilars that is meant to be the biological equivalent of the ‘Orange Book’, which lists pharmaceuticals and their generic equivalents.

European approval for biosimilar insulin

Partners Eli Lilly and Boehringer Ingelheim, announced on 10 September 2014 that they had received European Commission (EC) approval for its biosimilar insulin glargine product Abasria (LY2963016), a first for Europe.

Adalimumab biosimilar has comparable pharmacokinetics to Humira

An adalimumab biosimilar (CHS-1420) from fledgling biotech company Coherus Biosciences (Coherus) has shown comparable pharmacokinetics in a pivotal clinical study.

FDA accepts applications for three-times-weekly follow-on Copaxone

The US Food and Drug Administration (FDA) has accepted applications submitted by generics makers Dr Reddy’s, Sandoz (Momenta Pharmaceuticals’ development and commercialization partner), and Mylan for three-times-weekly follow-on versions of blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).

Infliximab biosimilar to be distributed by Mundipharma

Celltrion’s infliximab biosimilar Remsima will be distributed in Belgium, Germany, Italy, Luxembourg, The Netherlands and UK, exclusively by Mundipharma International and its independent associated companies. Remsima is a biosimilar of Johnson and Johnson (J&J) and Merck’s anti-inflammatory blockbuster Remicade (infliximab).

US senators call for guidance on biosimilars

A growing number of US senators are calling on the country’s Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) to release guidance on key scientific policy questions related to biosimilars.

The future of biosimilar use and regulation in Latin America

There is a growing uptake of biosimilars in Latin America, but this has not been accompanied by an increase in pharmacovigilance, training or regulation. To address this, an expert panel was put together to discuss the issues involved. The panel’s perspectives on the current status led to six major recommendations drawn up to enhance the safe use of biosimilars across the region [1].

Physicians believe biosimilars should have different names

In the ongoing debate over how to name biosimilars, US physicians have now added their opinion to the discussion.

FDA receives application for monoclonal antibody biosimilar

South Korean biotechnology company Celltrion announced on 11 August 2014 that the company had, on 8 August 2014, completed the filing procedure to obtain US Food and Drug Administration (FDA) approval for its infliximab biosimilar.

FDA grants tentative approval for insulin treatment

On 18 August 2014, the US Food and Drug Administration (FDA) granted tentative approval for a new insulin glargine product (LY2963016).

ECCO survey highlights lack of confidence in biosimilar mAbs

In a presentation at the EuropaBio and the Alliance for Safe Biologic Medicines (ASBM) roundtable on naming, transparency and traceability for biosimilars [1], held on 18 March 2014 in Brussels, Belgium, Dr Alessandro Armuzzi presented results of a survey of European Crohn’s and Colitis Organisation (ECCO) members [2]. The results of the survey highlight the lack of confidence ECCO members have in biosimilars and the need for continued education.

More biosimilars collaborations on the cards

Collaborations for biosimilars are still in vogue, with the latest companies making deals being PlantForm Corporation (PlantForm) with PharmaPraxis and Oncobiologics and Laboratorios Liomont.

WHO proposal offers clarity for biosimilar nomenclature

Following requests from drug regulatory authorities worldwide, the World Health Organization (WHO) has released a draft Biological Qualifier (BQ) proposal on which to base a globally recognized naming scheme for biological products, including biosimilars. According to the proposal, a four-letter code – the BQ – would be added after the INN.

Biosimilars in the treatment of chemotherapy-induced anaemia

A study of the use of epoetin biosimilars in the therapeutic management of anaemia secondary to chemotherapy in haematology and oncology has shown the biosimilars to be effective and well tolerated in the management of chemotherapy-induced anaemia in patients with solid tumours, lymphoma and myeloma [1].

Biosimilars of cetuximab

Last Update: 13 April 2018

Cetuximab is a chimeric (mouse/human) monoclonal antibody. It inhibits epidermal growth factor receptor (EGFR) and is used to treat metastatic colorectal cancer, metastatic non-small cell lung cancer and head and neck cancer.

Coherus starts phase III biosimilar etanercept trial

US-based biosimilars developer Coherus BioSciences (Coherus) announced on 23 June 2014 the start of a global phase III trial for a biosimilar version of etanercept.

Biosimilars deals coming thick and fast

Biosimilar collaborations are still the latest fashion, with new deals being made between Cipla and Mabpharm, Strides Arcolab and Oncobiologics, and NeuClone and the Serum Institute.

Switching and extrapolation of subsequent entry biologics in Canada

The regulatory framework for biosimilars in Canada explains how their substitutability and/or interchangeability are governed in the country. Biosimilars, which are known as subsequent entry biologics (SEBs) in Canada, are regulated in line with guidance from the World Health Organization.

Biosimilar infliximab receives approval in Japan and Turkey

South Korean biotechnology company Celltrion announced on 4 and 16 July 2014 that the company had received marketing approval for its biosimilar Remsima (infliximab) in Japan and Turkey, respectively.

Biosimilar trastuzumab similar to Herceptin in non-clinical study

Comparative non-clinical assessments of the proposed trastuzumab biosimilar PF-05280014 and the originator product (Herceptin) sourced in the US and in Europe showed similar structural properties, tumour cell growth inhibition properties and pharmacokinetic profiles, as well as safety profiles [1].

FDA accepts biosimilar filgrastim application

Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 24 July 2014 that the US Food and Drug Administration (FDA) had accepted its application for approval of the company’s biosimilar filgrastim product.

Biosimilars of darbepoetin alfa

Last update: 20 November 2020

Darbepoetin alfa is a synthetic form of erythropoietin. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.

Phase I studies of infliximab and rituximab biosimilars demonstrate pharmacokinetic similarity

Results of phase I trials of pharma giant Pfizer’s biosimilar infliximab and rituximab candidates have demonstrated similar pharmacokinetic properties compared to the originator products [1, 2].