Biosimilar drugs – a chance for better access to treatment

The expiry of patents for the most popular drugs, developed many years ago as a result of multi-million investments and based on multiple clinical trials, is one of the most significant problems, which international pharmaceutical companies face today. Many of the drugs became “blockbusters” (defined as a drug that exceeds global sales of $1bn per annum). Thus, a few years ago, the pharmaceutical leaders started to search for a solution to prevent the foreseen drop of sales resulting from the introduction into the market of generic drugs, constituting a counterpart for innovative drugs developed by other pharmaceutical companies once the “data exclusivity” period expires.

 

In search for new sources of income

The most common practices to avoid significant fall of sales are: the registration of drugs with new indications for use or with a new dosage form, taking-over of generic companies (e.g. a few years ago, the international giant, Sanofi, took over one of the biggest Central and Eastern European generic companies – Czech Zentiva), or expanding the areas of a company operation by entering e.g. dietary supplements, dermocosmetics or biological and biosimilar drugs markets. The situation on the market has been foreseen many years ago and the aforementioned actions has already been taken by some of the market players.

 

Biological drugs – the patents’ expiry phase has begun

The pharmaceutical market is entering the next phase – the expiry of patents on biological drugs. Contrary to traditional chemical drugs, biological drugs are made from living organisms and base on their genetic material. 

 

Expiry date for patents on selected biological drugs in European Union, 2015-2022
 
PMR, based on Bernstein research, 2013
Product Indications for use Approved by EU Expiry date - patent in EU Year
Epogen (epoetin alfa) Anemia 1 January 1989 Expired  
Rituxan (rituximab) Lymphomia, leukemia 2 June1998 Expired
Neopogen (filgrastim) Cancer/ neutropenia 20 February 1991 Expired
Erbitux (cetuximab) Cancer 29 January 2004 Expired  
Herceptin (trastuzumab) Cancer 28 August 2000 Expired
Remicade (infliximab) Rheumatic diseases 13 August 1999 Expired
Enbrel (etanercept) Rheumatoid diseases 3 February 2000 1 February 2015 2015
Synagis (palivizumab) Virus infections – children 13 August 1999 9 August 2015
Neulasta (pegfilgrastim) Infections – patients with tumors 22 August 2002 20 October 2015
Aranesp (darbepoetin alfa) Anemia 6 August 2001 6 July 2016 2016-2022
Humira (adalimumab) Rheumatic diseases 8 September 2003 16 April 2018
Avastin (bevacizumab) Cancer 12 January 2005 21 January 2022

 

 

Biosimilars – billion savings opportunity

In case of biological drugs, introduction into the market of the, so-called, first generic shall have a significant impact on both the system of drugs’ reimbursement and the patients, as biological drugs are much more expensive than the traditional ones. For example, the average cost of Cerezyme reaches approximately PLN 5,700 (€1,400), MabThera – PLN 5,200 (€1,200) and Humira – PLN 4,100 (€972, all the aforementioned drugs fall under the highest reimbursement level), while the average cost of traditional innovative drug available at pharmacies is PLN 29 (€7). It is worth to mention that the introduction of biosimilar drugs into the market results in lowering of prices by 25-50%. Few years ago, in Germany, the introduction into the market of a biosimilar drug for Erypo, caused a drop of prices in the referenced group by 51%. A similar decrease was observed in Poland, after the inclusion of biosimilars for filgastrim in the reimbursement lists. In such cases, the price of original drug also drops. In case of traditional chemical drugs, savings are noticeable, but less significant compared to biological drugs. In conclusion, following the IGES forecasts, based on IMS Health data, maximum total savings resulting from biosimilars’ development in the classes of growth factors, monoclonal antibodies and erythropoietin in Poland in years 2007-2012 shall reach the level of €1.3bn.

 

Opportunities and challenges for pharmaceutical industry

Taking the largest pharmaceutical concerns into account, it seems that AstraZeneca is the most heavily threatened by the expiry of patents on small molecule drugs in the next few years. Over half of the company’s revenues are generated by such drugs, and by 2018 patent protection on drugs such as Nexium, Symbicort, Crestor and Seroquel will have lapsed. However, if we consider biological drugs also, the situation looks much worse for the other the companies analysed. With regard to biologicals, companies such as Sanofi (the manufacturer of Humira) and Roche (the manufacturer of biological best-sellers such as Avastin, Herceptin and MabThera) are the most heavily threatened by patent expires in the next five years.

 

Leading pharmaceutical companies in the USA by 2012 sales of drugs* whose patents will expire within the next 5 years
* excluding biologicals
Note: example based on US sales.
Apteka.ua, 2014
Company Sales ($ bn) in 2012 (drugs whose patents will expire within the next 5 years) Total sales ($ bn) in 2012  Share (%) of small-molecule drugs whose patents will expire within the next 5 years as a proportion of total sales
AstraZeneca 7.250 10.655 68.0
Eli Lilly 4.617 10.650 43.4
Novartis 4.169 10.392 40.1
Bristol-Myers Squibb 3.359 10.384 32.3
Merck & Co. 3.728 13.243 28.2
Abbott 2.848 10.435 27.3
GlaxoSmithKline 1.847 10.645 17.4
Pfizer 2.410 17.821 13.5
Roche 1.385 14.778 9.4
Sanofi 0.775 9.072 8.5
Johnson & Johnson 1.845 12.421 6.7

 

Leading pharmaceutical companies in the USA by 2012 sales of drugs* whose patents will expire within the next 5 years
* including biologicals
Note: example based on US sales.
Apteka.ua, 2014
Company Sales ($ bn) in 2012 (drugs whose patents will expire in the next 5 years) Total sales ($ bn) in 2012  Share (%) of small-molecule and biological drugs whose patents will expire in the next 5 years as a proportion of total sales
AstraZeneca 7.861 10.655 73.8
Abbott 7.225 10.435 69.2
Eli Lilly 7.012 10.650 65.8
Sanofi 5.876 9.072 64.8
Roche 9.118 14.778 61.7
Novartis 4.169 10.392 40.1
Johnson & Johnson 4.388 12.421 35.3
Bristol-Myers Squibb 3.359 10.384 32.3
Merck & Co. 3.728 13.243 28.2
GlaxoSmithKline 1.847 10.645 17.4
Pfizer 2.410 17.821 13.5

 

Expiry of patents, including patents on biological drugs, will, definitely, have a significant impact on the Polish pharmaceutical market. However, we need to bear it in mind that in case of biological drugs, their counterparts will not be developed as fast as the generics for chemical molecules. Proving the bioequivalence of biosimilars is a very expensive and complicated process. Therefore, the traditional drugs’ counterparts shall be developed more often by international companies. Despite the general trend, there are few companies operating on the Polish market, already taking actions related to the field of biological drugs development. Mabion is developing a biosimilar drug for MabThera by Roche. Polpharma also has biosimilar drugs development plans and created a branch dedicated to this field of their activity.

 

Monika Stefańczyk

Head Pharma Market Analyst

PMR

monika.stefanczyk@pmrcorporate.com