Biosimilars ready to pounce on AbbVie’s Humira in Europe
Biosimilar companies are now gearing up to pounce on AbbVie’s inflammation blockbuster Humira (adalimumab) when it loses its patent exclusivity across Europe on 16 October.
Humira earned $6bn in ex-US sales for AbbVie last year, most of which came from Europe, and is expected to see revenues rapidly erode from early 2019.
Amgen’s copy Amgevita and Samsung and Biogen’s Imraldi both gained full EU approval last year, giving them lots of time to prepare the market before they are permitted to launch on the October red letter day. Meanwhile Sandoz (a Novartis division) announced on Friday that it too has now gained European approval for its biosimilar, to be known as Hyrimoz.
The biosimilars are expected to undercut Humira’s original price by 10-20%, and healthcare systems across Europe are getting used to driving hard bargains and exploiting competition between firms to get the lowest price possible. In some cases, this has seen originator companies matching prices of biosimilar entrants in order to hold onto their market share.
There are many more biosimilar companies looking to get a slice of the Humira spending in Europe, which according to IQVIA data, is worth £500m ($655m, €564m) annually in the UK alone.
Hyrimoz has been approved for use in all of Humira’s many indications rheumatoid arthritis, psoriasis and Crohn’s disease.
Kavya Gopal, Head of Specialty at Sandoz UK said: “The approval of Hyrimoz has the potential to have a positive impact on the NHS in terms of reducing medicines spend and will ultimately increase patient access to effective treatments. The NHS currently spends over £500m a year on Humira the availability of Hyrimoz in a competitive environment will provide the opportunity to lower the cost per patient, allow more patients to be treated and support a sustainable healthcare system.”
England’s budget holder NHS England expects there to be four adalimumab biosimilars available in the UK from 16 October 2018 – AbbVie’s ‘originator’ product Humira and the three biosimilars from Amgen, Samsung/Biogen and Sandoz.
As the potential savings are so great, NHS England’s Commercial Medicines Unit (CMU) is co-ordinating a national procurement process for adalimumab after the loss of patent exclusivity in October 2018.
NHS England says its ambition is for the NHS to achieve a recurrent annual saving of £200-300m by 2021 through the increased use of ‘best value’ biological medicines; this phrasing means it doesn’t preclude sticking with the originator product if they can provide this ‘best value’ price,
It says it has already achieved £210m savings from the use of biosimilar medicines (2018/19 figures).
Read the NHS’ internal briefing on adalimumab biosimilars from May
Hong Kong could be new biotech hub, says Beigene, heading for $1bn floatation
Beigene is part of a wave of new China-based biotech companies who are emerging rapidly thanks to new rules in Hong Kong’s stock market, HKEX.
Introduced in late April this year, the new rules allow biotech companies without revenues to launch initial public offerings (IPOs) – or allow companies already listed elsewhere to launch secondary listings in Hong Kong.
A total of eight companies in biotech research have filed since May, and now Beigene is planning the biggest yet.
Already listed on the US biotech specialist exchange Nasdaq, Beigene plans to float in Hong Kong on 8 August, and aims to raise up to $1 bn: this would be a record-breaking sum for a biotech company with no products yet on the market.
Speaking to the South China Morning Post, the company’s chief executive John Oyler (pictured) said:
“There are a lot of global investors who know biotechnology but who know very little about China. In Hong Kong, there are a lot of investors who know about China but know too little about biotechnology. We hope our listing in Hong Kong can help educate both of these types of investor.”
He added: “Hong Kong has the potential to attract many more biotechnology firms to list here as well as the investors to trade here. The research analysts and other related parties will follow. This will create an ecosystem for the biotechnology industry in Hong Kong.”
The Beijing-based biotech has topline data from a pivotal trial of its PD-1 inhibitor in Chinese patients with relapsed/refractory classical Hodgkin’s lymphoma, and is hoping to file for approval in its home market later this year.
Read biotech investor and commentator Brad Loncar’s blog on the eight biotechs which have already filed on the HKEX.
Kymab reports early data from lead antibody
UK biotech company Kymab has released phase 1 data from its OX40-Ligand monoclonal antibody KY1005.
The Cambridge, UK-based company had been tipped as one of the country’s brightest biotech hopes a few years ago, but hasn’t been quick in moving its candidates into clinical trials.
Now the company has some reassuring top-line phase I data which shows the antibody has favourable safety, pharmacokinetics and pharmacodynamic properties.
Kymab says the data supports taking KY1005 into patient phase II studies in patients with atopic dermatitis.
OX40 and OX40- Ligand (OX40L) has the potential to treat a number of immune mediated and inflammatory disorders, including uses in oncology.
A number of big pharma companies have 0X40 candidates in their pipelines, including Pfizer, although Roche abandoned its phase 1 candidate RG7888 in solid tumours last year.
RNA drug specialist Moderna also have their own OX40L candidate, mRNA-2416 in early stage trials.
In its next clinical study, KY1005 will be tested in patients with atopic dermatitis, a condition in which especially high levels of OX40L are found. The phase IIa trial in atopic dermatitis is expected to begin in late 2018.