Competition in the biosimilars market is getting intense as increasing numbers of generic equivalents of biologics gain acceptanace.

India’s fast-emerging biosimilars industry received a boost due to a new set of regulatory guidelines coming into force that are designed to ensure quality, efficacy and safety of biosimilars. The new regulations have also set the pace for the approval process of biologic products.

India issued guidelines for ‘similar biologics’ in 2016. Companies soon started launching low-priced versions of top-selling biotherapeutics, one after the other, leaving room for the market to expand further.

In January, Mumbai-based Glenmark Pharma introduced adalimumab, a biosimilar to AbbVie’s Humira. Sales of the rheumatoid arthritis treatment were $18.4 billion in 2017 and are estimated to grow to $21 billion by 2021. The TNF inhibitor is being prescribed for other auto immune disorders like plaque psoriasis.

In the same month, Hetero Drugs of Hyderabad also launched a biosimilar to adalimumab. A leader in antiretrovirals, the south Indian firm has already commercialized biosimilars to darbepoetin alfa, rituximab and bevacizumab. 

Earlier, Zydus Cadila of Ahmedabad came out with adalimumab, which is currently sold under the brand name Exemptia. Glenmark brought the drug to market under a licensing agreement with Cadila Healthcare. Glenmark and Hetero are relatively new entrants into the biosimilars scene.

Recently, Biocon, a pioneer in India’s biotherapeutics industry, secured approval for trastuzumab from the U.S. Food and Drug Administration (FDA). Biocon’s is the first biosimilar of Roche’s breast cancer drug Herceptin approved by FDA. Already listed among the World Health Organization’s (WHO) essential medicines, trastuzumab biosimilar presents a $6 billion global opportunity, reports estimate. Biocon partnered with Mylan for the development of the drug. The Bengaluru-based company’s R&D pipeline is rich with biosimilars including pegfilgrastim, insulin glargine and bevacizumab. It is looking at winning more approvals for the U.S. and EU markets.

Similarly, Sun Pharma received clearance from FDA for tildrakizumab for the treatment of plaque psoriasis. The Mumbai-based company licensed worldwide rights to tildrakizumab from Merck & Co. in 2014 and subsequently funded the Phase III trial of  the biologic. Sun Phrama will take full control of the product post approval. Tildrakizumab, which targets interleukin-23 (IL-23), will now compete with Janssen’s guselkumab as well as the other IL-17 therapeutics approved for the indication so far, such as ustekinumab (J&J), secukinumab (Novartis) and ixekizumab (Eli Lilly) in the psoriasis market in the U.S. IL-23 inhibitor biologics have an edge over IL-17 blockers as the former require fewer injections.

Lupin announced in May that the company submitted a new drug approval (NDA) for a biosimilar of etanercept in Japan through Yoshindo, its joint venture partner. Etanercept is the first biosimilar developed as part of the tie-up. Japan’s biologics market is estimated to reach $13.5 billion in 2019, according to the Lupin release. Lupin is planning to build the company’s biosimilars pipeline and expects to file for etanercept approval in the U.S. and Europe in the next couple of years.

As Indian companies tighten their grip on highly successful biologic products, industry experts are saying that the country’s biotherapeutics manufacturing sector is steadily maturing.

The companies enjoy a development and manufacturing advantage by working on the drugs in India. Biosimilars are starting to track the dynamics of small molecule products. The uptake of biosimilars globally will continue to grow as payers and governments look for more affordable drugs with assured quality. Players with unmatched quality standards and technical prowess stand to gain.

In addition, efforts are underway globally to harmonize regulatory guidelines. A dossier common for use both in the U.S. and European markets is currently under discussion. According to a recent CPhI report, “The dynamics of the biosimilar market are shifting towards congruence with the generics and adoption should now accelerate.”

But the hitch is, unlike small molecules, the making of biosimilars demands a much larger investment. Biosimilars require extensive clinical development and can cost upwards of $150 million. More than 80% of the total cost goes into clinical development of the molecule, whereas a chemical generic might cost only $1 to $5 million as it only requires BA/BE studies, analysts pointed out.

Notwithstanding the high costs, a handful of Indian companies are making huge bets investing in R&D and vying for a piece of the biosimilars pie that is estimated to be worth between $25 billion and $35 billion by 2020.