Three Keytruda biosimilars have been deployed by Russia- and Bangladesh-based biotechs ahead of patent cliff
The premature contenders are currently approved in four global markets but have the potential to expand across most regions
This might be compounded by future transgressors
Early biosimilar competition will potentially move forward the projected date of sales decline for MSD’s star performer
Stop worrying about Keytruda biosimilars, they’re already here. PHARMALERT data reveals that the Merck Sharp & Dohme (MSD) cash cow is now coexisting in the global market with three different copycats that have managed to stay under the radar.
This is not small news in the biopharmaceutical industry. After its 2014 launch, Keytruda (pembrolizumab) has consistently been MSD’s top performer since 2018 and last year became the best-selling drug in the industry, continuing to grow driven by new indications.
Sneaking into MSD territory
MSD has been cashing in on Keytruda’s success throughout its exclusivity period, the patent set to extend until 2028. The drug’s performance is giving investors confidence in the company, so much that a recent Phase III data readout in which Summit’s checkpoint inhibitor outperformed pembrolizumab did little damage to the stock.
However, the strain that high-cost biologic drugs have put on healthcare budgets and the resulting demand for affordable biosimilars are curtailing the exclusivity periods of some monoclonal antibodies (mAbs) in global markets. In the case of Keytruda, Russia-based drug makers Biocad and R-Pharm have developed their own versions of pembrolizumab under the brand names Пемброриа (Pembroria) and Арфлейда (Arfleyda) respectively, while Bangladesh’s Beacon Pharmaceuticals has deployed its copycat as Pemro/Pembroxim.
While a regulatory nod does not demonstrate that any commercialisation is taking place, the timing and location certainly arise suspicion considering that these milestones haven’t been reported in mainstream media.
Low-key markets but still within MSD’s scope
These early competitors are registered in Russia (Pembroria and Arfleyda), Belarus (Pembroria), Bangladesh (Pemro) and Kenya (Pembroxim). Their presence does not mean that these markets are neglected by MSD, as they actually coexist with Keytruda in Kenya and Russia.
In fact, in the case of Kenya MSD actually threw its hat into the ring even after Beacon Pharmaceuticals had registered its less expensive alternative, illustrating the US company’s steadfast interest in these regions. MSD’s latest financial statement shows that international (ex-US) markets raked in USD 2.9 billion in Keytruda sales during H2 2024, up 21% year-on-year and accounting for 40% of the drug’s revenue.
One point of contention is market size. It is true that a quartet of countries does not represent a large slice of the cake for MSD. Out of the four, the biggest impact to Keytruda sales comes from Russia, where the company should have already halted its commercialisation of the drug according to the measures taken in response to the invasion of Ukraine, which include restricting supplies to essential treatments, a label that no longer applies to Keytruda in the presence of Biocad and R-Pharm’s alternatives. However, the significance of the three premature biosimilars does not lie in their current impact on MSD sales but in how they might shake the market in future.
Today Belarus… tomorrow the world
It is tempting to argue that the new competitors are unlikely to get green-lit (or even submitted for review) in nations with more stringent regulatory authorities, downplaying the approvals in Russia and Bangladesh as means to support the biopharmaceutical industries in those nations. While it is true that the regulators of the markets identified here do not hold WHO-Listed Authority status, the cross-border nods from Belarus and Kenya attest for the premature biosimilars’ ability to exploit the pressing need that some nations have for affordable alternatives to a medicine that has a listed price of USD 11,564 per dose in the US.
The list of countries where Beacon, Biocad and R-Pharm have a footprint can offer insight into the directions in which their pembrolizumab products will expand next. Biocad has the upper hand in terms of experience having registered other biosimilars (including rituximab, trastuzumab, and bevacizumab molecules) in 15 foreign markets across Asia, Eastern Europe, Latin America and North/Eastern Africa, not to mention that its homegrown biologics levilimab, prolgolimab and netakimab are present in Belarus, with the former currently under review in Brazil.
Russian compatriot R-Pharm also boasts a global footprint thanks mainly to its CMO subsidiary in Germany producing generics for 13 markets in Asia, Latin America, Sub-Saharan Africa, as well as Europe (covering Norway, the UK and members of the European Medicines Agency). It also has a COVID-19 vaccine registered in Saudi Arabia, as well as two mAbs in Belarus including innovative biologic olokizumab.
Finally, Bangladesh’s Beacon has placed its generics in Bolivia, Philippines and the UK.
In addition to their familiarity with the regulatory framework in these regions, these developers can also benefit from the post-launch data that has been accumulating in the four current markets to support further expansion of their pembrolizumab biosimilars.
Projections for Keytruda commonly assume long exclusivity periods with global contenders playing by the rules, but the reality is that some of the smaller markets on the blind side have flourishing biotechnology industries that can help alleviate budgetary constrains domestically and in other overlooked countries. While not an immediate catalyst, these early competitors suggest that the inflection point for Keytruda sales might be closer than anticipated, especially as they expand into other markets.
This could be only the first wave
The impact of Biocad’s Pembroria, R-Pharm’s Arfleyda and Beacon’s Pemro/Pembroxim will be compounded down the road by additional competitors. While the long list of late-stage pembrolizumab candidates is currently spearheaded by Amgen, Formycon, mAbxience, Samsung Bioepis and Sandoz, the business model of Big Pharma companies makes it unlikely for them to challenge MSD’s exclusivity period.
This is not the case for many biotechs that choose to fully or partially conceal their pipelines, approvals or launches. While it is impossible to identify which among the myriad of drug developers that exist globally might be planning to commercialise Keytruda biosimilars before 2028, PHARMALERT’s analysis demonstrates that it is possible to catch them as soon as they obtain regulatory approval in markets where they feel safe, operating far from the gaze of the pharma industry media.
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