Mabwell’s adalimumab biosimilar wins BPOM nod: Is Southeast Asia becoming the next battleground for biosimilars?

Mabwell (688062.SH) has secured marketing authorization in Indonesia for its adalimumab biosimilar injection, 9MW0113, developed in partnership with Junshi Biosciences. The approval by the Indonesian Food and Drug Authority (BPOM) marks Mabwell’s third overseas regulatory win in 2025, signaling deeper penetration into emerging Southeast Asian markets with high biologic demand and stringent regulatory oversight.

This milestone makes 9MW0113 the first adalimumab biosimilar independently developed in China to be approved by BPOM, and expands Mabwell’s footprint across multiple regions where registration filings are underway, including Jordan and Peru. The authorization supports the company’s long-term biosimilar export strategy and positions it to challenge established biologic players in cost-sensitive but quality-driven emerging markets.

Why Indonesia’s approval could reposition Mabwell in the global biosimilar race

The approval in Indonesia is not just a regional win. As a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), BPOM’s endorsement is viewed as a marker of quality on the international stage, especially among middle-income countries evaluating cost-efficient alternatives to high-priced originator biologics.

Mabwell’s 9MW0113 was previously commercialized in China under the brand name JUNMAIKANG, already competing in one of the world’s largest biosimilar markets. By receiving the green light from Indonesia’s regulator, the product gains potential traction across Southeast Asia, where countries increasingly reference PIC/S-aligned approvals to inform their own regulatory processes.

For Mabwell, this creates a gateway effect. Success in Indonesia strengthens its credibility in nearby ASEAN states such as Vietnam, Malaysia, and the Philippines, each with expanding biologics demand, constrained public budgets, and a growing openness to biosimilar therapies as they mature beyond first-generation anti-TNF agents.

How Mabwell’s partnership strategy with Junshi Biosciences is shaping its expansion playbook

While Mabwell is leading the commercial effort, the biosimilar was co-developed with Junshi Biosciences—a company best known for its PD-1 inhibitor toripalimab and expanding presence in immuno-oncology. The strategic alliance reflects a broader trend among Chinese biotech firms pooling development and regulatory capabilities to accelerate cross-border commercialization.

This joint development model provides Mabwell a dual advantage: scientific credibility from its collaboration with an oncology-first innovator and operational leverage to scale production and navigate regulatory hurdles more efficiently. Such partnerships also enable risk sharing, which is increasingly critical in biosimilar markets where price competition can rapidly compress margins post-launch.

With formal cooperation agreements now signed in over ten countries, Mabwell appears to be building a multi-market pipeline anchored around a common regulatory and manufacturing backbone, possibly reducing redundant development costs.

What is the competitive positioning of 9MW0113 in a crowded adalimumab biosimilar market?

Adalimumab remains one of the world’s highest-revenue biologics, even with AbbVie’s Humira facing biosimilar erosion in major markets like the United States and Europe. The molecule has become a benchmark for biosimilar capability because of its complex structure, immunogenicity risks, and historical pricing dominance.

Globally, multiple players have launched or filed for adalimumab biosimilars, including Samsung Bioepis, Amgen, Sandoz, Boehringer Ingelheim, and Biocon. Mabwell’s 9MW0113 enters the fray with limited first-mover advantage but an opportunity to compete aggressively on price and supply stability in underpenetrated markets.

Unlike mature markets where interchangeability, payer alignment, and marketing scale determine success, emerging markets like Indonesia prioritize access, cost reduction, and basic pharmacovigilance compliance. Here, Mabwell’s integrated manufacturing platform and BPOM endorsement could be sufficient to command early market share—especially in public tenders and formulary listings where budget constraints dominate.

What regulatory and market risks remain as Mabwell scales its international biosimilar rollout?

Despite the strategic upside, several execution risks remain. First, while BPOM’s approval signals quality, it does not guarantee rapid reimbursement or public procurement success. Many countries in Southeast Asia rely on multistakeholder pricing negotiations, and biosimilar pricing floors are often tightly managed to avoid destabilizing domestic manufacturing ecosystems.

Second, distribution and physician uptake in biosimilar-naïve or brand-loyal markets can be slow. Even in systems welcoming biosimilars, it may take time to overcome prescriber inertia or originator-driven marketing.

Third, Mabwell’s financials and manufacturing scale will be stress-tested as it expands. Export-driven biosimilar strategies require sustained investment in regulatory affairs, local partnerships, and cold-chain logistics. These efforts must be matched with gross margin discipline—especially given that adalimumab’s global biosimilar price erosion has already begun to compress returns for earlier entrants.

Does the Indonesian approval change Mabwell’s position among Chinese biosimilar exporters?

The latest development puts Mabwell in a stronger position among China’s second-tier biosimilar developers. While the first wave of Chinese biosimilar firms focused on the domestic market, a growing number are now following a “China plus emerging markets” playbook—pursuing ASEAN, Middle East, Latin America, and parts of Africa where regulatory alignment with China is improving.

Mabwell’s win also helps shift perceptions of Chinese biosimilars from low-cost alternatives to globally competitive options that meet international quality benchmarks. This could influence procurement agencies in other emerging economies to evaluate Chinese-developed biologics more seriously, particularly as cost pressures in public health systems intensify.

However, Mabwell remains a challenger rather than a dominant force internationally. Without a differentiated biosimilar platform or large-molecule pipeline edge, its long-term competitiveness will depend on how fast it can execute across multiple markets before others catch up.

Key takeaways: Mabwell’s Indonesian approval offers regional credibility, but global success will hinge on scale, pricing, and execution

• Mabwell and Junshi Biosciences received Indonesian BPOM approval for 9MW0113, a biosimilar version of adalimumab, marketed in China as JUNMAIKANG.
• The approval makes it the first Chinese-developed adalimumab biosimilar to be cleared by BPOM, reinforcing regulatory credibility beyond China.
• Indonesia’s status as a PIC/S member enhances the signaling value of this approval, potentially easing entry into other ASEAN and emerging markets.
• The co-development with Junshi Biosciences reflects a broader collaboration model in Chinese biotech aimed at accelerating overseas entry.
• Mabwell is pursuing a low-cost, multi-market strategy amid a highly competitive global adalimumab biosimilar landscape.
• Challenges include pricing pressure, physician adoption inertia, and execution risk across geographies with limited biosimilar maturity.
• This move strengthens Mabwell’s positioning among Chinese biosimilar exporters, but future wins will require deeper market development capability.
• The broader signal: Southeast Asia is becoming an important testbed for Chinese biopharma internationalization.