The growing intellectual property concerns and vast market projection of $ 55 billion by 2020 represents huge growth prospects for biosimilar products in the near future.
Biosimilars are biological medicines that are highly similar to an already authorised reference medicine yet priced more competitively. The biosimilars market is expected to grow over the next few years as originator products lose their exclusive licence, with payers seeing them as an important way to reduce costs on already stretched healthcare budgets.
With growth primarily driven by a promising pipeline in active development and government efforts to reduce healthcare spending, the global biosimilars market value is expected to reach $20 billion by the end of 2015 and could hit $55 billion by 2020, according to the business intelligence provider GBI Research.
Globally, a varied groups of biologics are coming into the market which range from monoclonal antibodies, growth hormones and cytokines to vaccines.
On the other hand, several innovator biologics are reaching their patent expiration which has propelled several bio-pharma companies to pursue production of biosimilars due to its higher return on investment because of the promising market potential according to industry.
The latest CBR Pharma report of GBI Research states that biologics currently account for between 17–20 per cent of the pharmaceutical arena, with a value of nearly $200 billion, and these products may replace 70 per cent of chemical drugs in the next two decades.
According to Sumith Ladda, Analyst for GBI Research, the 30 to 50 per cent reduction in biosimilar prices compared with branded biologics could lead to considerable savings in healthcare expenditure.
“There are currently 642 biosimilar trials being conducted, with 146 unique molecules. Biosimilars are most focused on oncology therapy, with a 36 per cent share, while immunology treatment comprises 21 per cent of the pipeline, meaning these two segments account for more than half of the total", says Ladda.
“Historically, simple proteins, such as filgastrim and epotien, were the prime targets of biosimilar development, but the focus has now shifted to complex monoclonal antibodies (mAbs), as there are numerous blockbuster mAbs going off-patent.”
GBI Research’s report also states that while a regulatory framework for biosimilars has been established in all major markets, some aspects, such as interchangeability, naming conventions and extrapolation across indications, need to be harmonized.
"The European Medicines Agency has the most robust and longest-standing guidelines for biosimilars. Countries such as Japan, China, and South Korea have developed guidelines similar to these",Ladda adds.
“The US Food and Drug Administration finalized guidelines for biosimilars in 2014 and approved its first biosimilar, Zarxio, on March 6, 2015. This marks the entry of biosimilars in the US, and has increased industry confidence in the country’s biosimilars market.”
The analyst adds that the US biologics space is twice the size of its European equivalent by value, but the uptake of biosimilars in Europe is nearly four times higher, indicating the significant future potential of biosimilars in the US.
Kiran Mazumdar-Shaw, chairperson, Vision Group on Biotechnogy and chairman and managing director, Biocon in her message to shareholders says “We have consistently invested nearly 10 per cent of our biopharma revenues in research and development. We have made long-term investments in creating ‘best-in-class’ complex biologics manufacturing capabilities. We are making a huge difference globally through affordable insulins, statins and monoclonal antibodies. We seek to extend our presence in niche areas where we see the potential to moderate costs . Our steadfast commitment to innovation has enabled us to develop novel biologics and complex, yet affordable, biosimilars for chronic diseases. Insugen, Basalog, BioMAb EGFR, Abraxane, CanMAb and Alzumab which are an outcome of our ‘patients-first’ strategy and a differentiated portfolio.
Out of the 11 drugs, three drugs are from Bristol-Myers Squibb: Baraclude or Entecavir and Abilify or Aripiprazole, Sustiva or Efavirenz . Two drugs are from Teva Pharmaceuticals: Copaxone or Glatiramer acetate and Provigil or Modafinil. One drug each from six global pharma majors are Novartis’ Gleevec or Imatinib mesylate, Forest Laboratories: Namenda or Memantine HCI, Boehringer Ingelheim: Combivent or Albuterol and ipratropium inhalation. Pfizer’s Zyvox or linezolid. Janssen Therapeutics: Prezista or Darunavir. GlaxoSmithKline: Avodart or Dutasteride, said Deepa ES, Patent Analyst, Origiin IP Solutions LLP.
Biosimilars are copied versions of biologics that offer a 20-50 per cent reduction in cost compared with innovative biologic products. Biosimilars are getting the world wide attention as the cost of the innovative biologics are enormously high and even minimal reduction in price will reduce the healthcare spending substantially.
All the countries are focusing on reducing the healthcare expenditure and biosimilars compliments to this goal.
Biologic products are complex in structure and follow a complex manufacturing process thus, some variation exists between the reference product and its biosimilar.
It is very important to assess the variations in biosimilars by comparing with reference product to ensure quality, non-clinical, and clinical properties, which has given rise to the regulatory requirements for biosimilars. Regulatory requirement for approving biosimilars varies across different regulatory bodies. However, all the countries have derived the basic theme from EMA and WHO guidelines for framing their regulatory structure. There is a need to harmonize the nomenclature of biosimilars, extrapolation of indications, and interchangeability of biosimilars with reference products across the regulatory bodies. Biosimilars market is developing and it could be well established with the pipeline that is poised to deliver a wave of biosimilars in the market in the near future
However drug regulators have noticed a proliferating problem. Around the world, various regional regulators are applying different naming conventions for biosimilars. So several regulators asked the World Health Organization (WHO),which has responsibility for giving drugs their generic names under the International Non-proprietary Name (INN) programme, to devise a global nomenclature for biosimilars.
Since 2013, the WHO has been working on a proposal that will provide a unique identification code called a Biological Qualifier (BQ) for all biological medicines, including biosimilars, and it hopes to complete its consultation process by October 2015.
“This is about patient safety,” says Raffaella Balocco-Mattavelli, manager of the INN programme, who is working closely on the project. A global unified naming system is central to ensuring the safe use of biosimilars — from the identification of the product in the clinical setting to its traceability after it reaches the patient, say its supporters.
The proposed Biological Qualifier scheme was set out in a July 2014 draft, which was discussed at a closed meeting in Geneva from April 13–15,2015 — the WHO’s 60th consultation on INNs for pharmaceutical substances. The majority of respondents to the WHO proposal were in favour of it, according to Balocco-Mattavelli.
Biosimilar products can be relatively small molecules, such as human insulin, or complex medicines, such as monoclonal antibodies . They have been called different things too, including similar biotherapeutic products (SBPs), follow-on biologics and subsequent entry biologics. The WHO defines them as: “a biotherapeutic product that is similar in terms of quality, safety, and efficacy to an already licensed reference biotherapeutic product.”
However, biosimilars are derived from living organisms and demand a more complex regulatory pathway from simple generic medicines. This is because of the difficulty of establishing comparability between products. This is down to various factors, including the product’s complex structure and manufacturing process, the difficulty in achieving consistency among batches, and in their complex long-term clinical effects. Biological active substances account for more than 40 per cent of applications to the INN programme and the percentage is increasing, says the WHO.
Now, as an increasing number of biosimilars are approved, a variety of naming systems have been adopted in different jurisdictions. In several places, a distinctive non-proprietary identifier is added as a qualifier. In Japan, for example, the qualifier is simply the code ‘BS’, such as ‘epoetin alfa BS’. In Australia, ‘epoetin alfa’ was registered by the Therapeutic Goods Administration (TGA) as ‘epoetin lambda’.
In other examples, the company is identified in different ways: ‘Filgrastim Hexal’ in Europe; ‘Tevagrastim Teva’ (for Laboratorio Teva) and ‘Filgrastine Blau’ (for Laboratório Blau Farmacêutica) in Brazil; and ‘Filgrastim-sndz’ in the United States (for a ‘Sandoz’ marketed product).
In other countries, a proprietary name alone is used, in South Korea, Celltrion’s biosimilar of Roche’s trastuzumab is called ‘Herzuma’; and Celltrion’s biosimilar of Johnson & Johnson’s Remicade (infliximab) is branded as both ‘Remsima’ and, in Europe specifically, as ‘Inflectra’.
However, under the WHO naming proposal, the BQ would consist of a four-letter code suffix assigned at random, resulting in names such as ‘filgrastim-bcdf’ and ‘filgrastim-wxyz’. The code would also be attached to the manufacturing site where the biosimilar is made, which has been criticised by industry groups. For instance, a company could have two different codes for the same biosimilar product manufactured at two different sites.
Such a suffix allows for 160,000 combinations of the four letters (excluding vowels). “This will provide sufficient flexibility for the foreseeable future,” the WHO contends. The proposed BQ scheme would apply to all biologicals assigned an INN and it would be applied retrospectively. A database would be created to hold all the codes issued. The BQ scheme would be universal but complementary to systems in place nationally, and its adoption by regulatory agencies would be voluntary.
Given the fast growth of the biosimilars sector , getting their names right is going to be crucial in future years.