Recently in the global pharmaceutical industry, corporations that had focused on generics (synthetic drug copycats) are pursuing a series of mergers and acquisitions (M&A) to enter the biosimilar (biosimilar) market.
Analysts say this is not a simple expansion in size but a strategic move to replace generic businesses facing stalled growth and to strengthen dominance in the biosimilar market.
According to the pharmaceutical and biotech industry on the 4th, there were two announcements in April alone about acquisitions of biosimilar corporations.
First, U.S. major generic company Amneal Pharmaceuticals said it would acquire biosimilar specialist corporation Kashiv Biosciences for about $1.1 billion (1.6 trillion won). Then India's largest drugmaker Sun Pharma drew industry attention by saying it would buy U.S. Organon for $11.75 billion (about 17 trillion won).
Amneal made clear its strategy to break away from a generics-centered business structure and make biosimilars a core growth pillar. Through the Kashiv acquisition, it secured integrated capabilities from development to manufacturing and global production facilities, laying the groundwork for expansion. Sun Pharma is also aiming to enter the global top tier by simultaneously strengthening women's health and biosimilars through the Organon acquisition.
The leading players in the biosimilar market include Celltrion, Samsung Bioepis, Amgen, and Sandoz. The rise of new latecomer corporations is linked to changes in the pharmaceutical industry structure and the regulatory environment.
First, the market has entered a "second patent cliff" phase, in which monopoly rights for large original drugs that have dominated the global market are being lifted en masse. According to the industry, patents will expire between 2024 and 2030 for drugs whose combined annual sales amount to about $200 billion (about 295 trillion won).
In fact, the autoimmune disease therapy "Stelara" saw full-fledged biosimilar competition begin with the expiration of its U.S. patent in 2023. The world's top-selling immuno-oncology drug "Keytruda," with annual sales exceeding $25 billion, is also approaching patent expirations in Korea and the United States in 2028, intensifying development competition among bio corporations.
Sandoz CEO Richard Saynor said at the JP Morgan Healthcare Conference in January that "well over $600 billion worth of medicines are expected to lose exclusivity over the next 10 years," calling it a "golden decade of unprecedented opportunity."
Robust "biosimilar-friendly policies" by governments are also influencing these strategies by corporations. As medical costs surge due to global aging, governments in the United States, Europe, and elsewhere have made biosimilars, which are 30%–50% or more cheaper than original drugs, a key to easing the burden on health care finances.
Governments are actively encouraging wider biosimilar use and speeding improvements to the regulatory environment. With the implementation of the Inflation Reduction Act (IRA), the United States has moved to negotiate drug prices directly and has also rolled out carrots such as raising the incentive (additional charge) paid to medical institutions for prescribing biosimilars compared with the past.
As clinical requirements are streamlined, led by the U.S. Food and Drug Administration (FDA), the development period for biosimilars is being shortened from about seven years to around five, and the expense structure is changing so that costs are cut by nearly half.
Europe, through the "Pharma Package" agreed at the end of 2025, shortened the data exclusivity period for original drugs and significantly strengthened the "Bolar Exemption," which allows products to be launched immediately upon patent expiration.
Another reason investment continues is that biosimilars have relatively high barriers to entry.
Generics can be produced at relatively low expense if the chemical formula is known, leading to dozens or even hundreds of corporations crowding into a single item. This inevitably results in fierce price competition and deteriorating profitability.
By contrast, biosimilars handle living cells, so they require high-level culture technology, large-scale facility investment, and large clinical trials, which limits the corporations that can enter initially. In other words, unlike the bloodletting competition in the generics market, biosimilars can be oligopolized if a player has strong technology and capital.
Attention is also on whether the string of M&A deals will reshape the biosimilar market landscape. While some say competition will intensify as biosimilar corporations increase, others analyze that the market is likely to harden into a "big-player-centered structure" reorganized around a few large corporations.
An industry official said, "In the biosimilar market, not only technological competition but also cost reduction through large-scale production facilities and sales power leveraging a broad portfolio are important," adding, "Depending on economies of scale by corporation and strategies to accelerate businesses, the global market share landscape could change."
The official added, "However, unless a latecomer slashes prices dramatically through innovative process improvements, it will not be easy to surmount the wall of the top three to five corporations that already have solid data and supply chains."