Current situation of biosimilars


Current levels of penetration

Global market

The nascent global market in biosimilars could see an acceleration in the next two years and increase its share in the biologicals segment from 1% to 5% by the end of 2017, according to data from Smart Pharma Consulting. This growth will be based mainly on the expiry of patents and the arrival biosimilars for MabThera, Herceptin, Erbitux, Remicade, Enbrel, Neulasta, Synagis or Aranesp which, in 2014, had a combined sales volume of around €70 billion.

European market

In Europe, since 2003 when the European Medicines Agency (EMA) took over the regulation of the biosimilars market, 21 drugs of this type of been approved. It is one of the most mature markets, accounting for 80% of global spending on biosimilars according to Deloitte.

The GPhA Biosimilars Council indicates that, in Spain, France, Italy, the United Kingdom and Germany, the market penetration of biosimilars is between 30% and 40%.

Spain is the sixth country in terms of penetration. The biosimilars market in Spain is worth about €40 million according to Ángel Luis Rodríguez de la Cuerda, Director General of AESEG, the Spanish Association of Generic Medicines.

United States market

On 2 September, after months of litigation, the first biosimilar started to be marketed: Zarxio (filgrastim) from Sandoz.

This step is a milestone in the world’s largest pharmaceutical market, which has seen the most hesitant entry of these products to date.



Express Script, 2014

Latin American market

A more rapid penetration of biosimilars is seen in this market. According to data from the consultancy Frost & Sullivan, the biosimilars market in Latin America had a turnover of $123 million at the end of 2013.

A recent report published by Deloitte has highlighted that the regulatory context and the interests of domestic and international manufacturers are factors that give a great boost to the biosimilars market in Latin America. In the Brazilian market, biosimilars have been acquiring greater weight, supported by an advanced regulatory framework, and it is expected that sales in the country will pass from 79 million in 2014 to 345 million in 2019.

In Mexico, although no biosimilar has yet been approved, there are various drugs under assessment at various stages of the process and it is hoped that at least one of these will be approved this year.

Level of knowledge and acceptance

The survey of 225,000 medical specialists in the United States by New Quantia has shown that 94% of those surveyed recognised the great value of biosimilars for healthcare systems, both in the reduction of costs and in the increase of access to treatment. However, it can be seen from the survey that only 17% of specialists said that it “is very probable” that they would prescribe biosimilars to their patients, through fear of questions related to efficacy and the regulations on substitution, among other factors.

The studies show that despite the growing recognition and acceptance of these drugs
within the scientific and medical community, the great effort is still needed to extend the knowledge among specialists and from there to translate it to patients.


Asebio Report, 2014

Business iniciative

The activity of the various companies and laboratories that operate in the biosimilars market is tied up with the existence or otherwise of a legal framework that favours a propitious scenario for their approval and subsequent marketing.

Therefore business initiative is faced with the challenge of regulatory insecurity concerning the development and subsequent commercialisation process of drugs that are presented as a great opportunity for national health systems, and also with the need for a large investment, quoted as $100–200 million to start up a business with these characteristics according to BioTrends Research Group.

Similarly, it should be noted that the development of biosimilars requires a large investment that varies between $75 million and $250 million, as opposed to $2–3 million required for the development of a generic drug.

Regularoty context

In Europe, the procedure for approval of biosimilars is subject to the approval criteria of the EMA, which is the organisation that has the last word in this domain. Spain is governed by these regulations, and also has other sources of law, including European directives.